Quality Assurance

OBJECTIVES:

  • To provide a procedure for Good Documentation Practices to be followed and for correction of any documentation error occurred during Documentation of data in all operating departments.

RESPONSIBILITY:

  • All the personnel of Operating Department to implement.
  • All the Department Heads to ensure compliance.

PROCEDURE: 

General Requirements:

  • Document is an organized form of information that can serve as legal evidence or proof. It ensures all personnel know what to do and when to do it “If it’s not documented, it’s a rumour, If it’s not signed, it’s graffiti”.
  • Documents should be simple, short and clear.
  • The GMP record should be such that “by looking at the record, one should be able to reconstruct the sequence of activities which were carried out”
  • Document should not be changed without appropriate authorization.
  • Data entries made in the documents shall be clear, legible, accurate, permanent and complete.
  • Accurate and Complete recording of data shall be made immediately after completion of a step or a process by person actually performing the activity.
  • Never sign for anything you have not done yourself
  • Handwritten entries / Signatures on documents must be made using permanent (indelible) blue or black ink. Erasable ink, non-waterproof ink, and pencil are not permitted.
  • Effective date on all the documents (wherever applicable) shall be put with Blue ink.
  • All entries shall be made directly onto the official record or document. The use of post-it notes, or unofficial notes to record data is not permitted.
  • If any page(s) left blank, draw a line across the page and write `Cancelled’, sign with date.
  • Ensure that no columns in records / documents are left blank. In case no entry is required in a particular column / page, draw a line across the columns / page and write `NA’ (Not Applicable).
  • In case, no comments are required, write `NIL’.
  • In case of batch records, if a page / in-process format is not used, put the “NOT USED” stamp on each unused page.

Data Integrity :

  • “Data Integrity” can be defined as accuracy and consistency of data.
  • Data integrity requires accurate and complete recording of data at the time the activity is performed.
  • Data integrity requires adherence to documented requirements such as policies,processes, procedures etc.
  • Data integrity requires verification of accurate data transcription, calculations etc.

Rectification of Documentation Errors:

  • All personnel shall avoid making data entry errors.
  • In case of wrong entry or error(s) made during documentation, the correct entry shall be made by following the below mentioned procedure.
  • Do not overwrite the wrong entry, cross it out with a line, clearly write the correct entry near the cross out, sign and put date on which the correction was made
  • In case where complete sentence or paragraph or page is not required, strike it off with a single line, mentioning the reason for not using or deletion (wherever applicable) and sign with date.
  • If the correction is made on a later date of original entry, the rectification shall be made as above and additionally it shall be counter signed and dated by Head of the department or immediate superior.
  • Under no situation the correction shall be made using artificial means. (e.g.whitener, eraser, etc.)
  • Data entry errors shall be corrected by the originator who made the data entry.Incase the error correction is to be made by an individual other than the originator,then information should be retrievable from an official documented source(Objective Evidence).
  • E-Mails shall not be used as objective evidence. Information from E-mails can be summarized in an official memo signed by the appropriate personnel.
  • Incase of document corrections, the reason for document corrections / Sign & Date shall be documented as close as possible to the correction.

Handwritten Signatures / Date Formats:

  • Signature can be an indication and/or verification of document correctness,completion of a task, approval or review, acknowledgement of receipt, correction of document etc.
  • An individual performing the activity may not review, verify or approve that activity.
  • Initials shall be avoided during the approval of official GMP documents.
  • Signatures are incomplete without correct date on the document.
  • Date shall be in ” dd/mm/yy ” or ” dd/mm/yyyy” formats. [dd, mm, yyyy expressed numerically & separator can be “/”, “-” or “.”].
  • Signatures (Full signature & Initial) shall be consistent with signatures recorded inthe specimen signature file.
  • Backdating & Postdating shall not be done.
  • Approvals shall be done by authorized personnel only.

Handling Damaged data:

  • When a record containing raw data is damaged and can no longer be used, the original data must be transcribed to a replacement record. 
  • The damaged original record must be attached to the replacement record unless it is contaminated with hazardous material. Incase of contamination the damaged record shall be discarded by giving an explanation and the same shall be verified by QA prior to discarding the damaged record.

DOCUMENTATION:

  • Formats: Nil
  • Reference Annexure’s: Nil.

—————Document End—————

To Get the full sop and annexures in word format contact in contact Form:The cost of the SOP INR 200 Approx $ :-3

OBJECTIVE:

  • To lay down the procedure for the preparation approval, review and control of Guidelines.

RESPONSIBILITY:

  • All the personnel of Factory to be familiar with this procedure.
  • The approver to ensure that all proposed Guidelines conform to this SOP before approving any Guidelines. 
  • Head- QA or his designee to ensure the controlled distribution of Guidelines.

PROCEDURE:

  •  Definition of Guidelines:
  • Guidelines are only “Indicative in Nature”. Persons responsible for carrying out the activity given in Guidelines shall refer to appropriate portion of the Guidelines and or follow the Guidelines as applicable.
  • All the Guidelines are to be generated by Computer on the format known as “Guidelines” (Refer Annexure 1). Various columns in the format shall be filled as described below.
  • Guideline number:This is unique number given to each Guideline.
  • This number consists of Nine
  • Characters as described below.
  • The first character is Alphabet “G” indicating Guidelines.
  • The next two characters are letters denoting department code. The code for each department is enclosed as Annexure 2.
  • The next three characters are serial numbers starting from 001 in the sequential order within the department.
  • The seventh character is “- “  dash.
  • The last two characters denote revision number. The first time any Guideline is prepared shall be numbered as “00” and first time any Guideline is revised shall be numbered as “01” and so  on.
  • Example: The first Guideline prepared for Quality Control department shall be numbered as “GQC001-00” and same when revised for first time shall be numbered as  “GQC001-01”.
  • Page No:Give the specific page no. as well as total pages computing the Guideline, example:1 of 5.
  • Department:Give the name of the department for which the Guideline is prepared. Example: Quality Control
  • Title:Give the detailed heading of the Guideline.
  • Effective Date: The effective date is the date when the content of the Guideline becomes operational after training of the concerned personnel on the Guideline.
  • Initiated By:The person, who prepares the Guideline, shall sign with date in this column. The operating  personnel of the respective department shall prepare the Guideline.
  • Approved By:Each Guideline shall be approved by respective functional head.
  • Authorized By:Each Guideline shall be authorized by Head- QA.
  • The typical guideline may have following headings.
  • 1.Objective 2.Responsibility 3.Procedure. 4.Documentation.
  • Objective:An overview of the intent of the Guideline shall be briefly mentioned here. It shall be numbered as ‘1.0’
  • Responsibility Specify the personnel to whom the Guideline is applicable. It shall be numbered as ‘2.0’.
  • Procedure:Describe the detailed procedure to be followed as required, in simple and clear sentences. It may include the details of all operations, operational conditions and precautions to be taken, safety instructions if any etc. It shall be numbered as ‘3.0’.
  • Documentation: . It shall be numbered as ‘4.0’. Documentation shall include the list of Formats & Reference Annexure’s referred in the procedure under two sub headings – 4.1 Formats & 4.2 Reference annexure’s.
  • Formats are documents which are required for execution of an activity. For e.g., usage logs, work permits etc. Appropriate formats, specimen labels etc. need to record the compliance of the guideline shall be included in the ‘Formats’ sub heading.
  • Reference annexure’s are documents which are required for reference during the execution of an activity. For e.g., Department/area codes, location drawings etc. All the reference annexure’s mentioned in the procedure shall be included in the ‘Reference Annexure’s’ sub heading.
  • Each Format / Reference Annexure shall be given a number. The number consists of 13 characters.
  • The first character ‘G’ denotes guideline.
  • The next two characters denote department code as mentioned above.
  • The next three characters denote serial number of guideline.
  • Seventh character is “ – “ dash.
  • The eighth character is “ F “ denotes format and “A” denotes reference annexure.
  • The ninth and tenth characters denotes serial number of the format / reference annexure of that particular guideline.
  • The eleventh character is “-“ dash.
  • The last two characters denotes the revision number of the respective format./reference annexure.
  • Example: GQA001-F01-00 is the first format, made first time and related to first Guideline of QA department and GQA001-A01-00 is the first reference annexure, made first time and related to first Guideline  of QA department.
  • Format number / reference annexure number shall appear on left bottom of the format.
  • A copy of each format / reference annexure shall be enclosed with respective guideline. Format shall be stamped as “ Specimen” and signed with date by the Head of QA or his designee and Reference annexure shall be signed with date by the Head of QA or his designee.
  • Submission of New Guideline:
  • The initiator of the Guideline shall prepare the draft copy of the proposed guideline based on above guidelines and forward it to department head for review and comments. Based on the comments received, necessary changes shall be done by initiator and changed copy forwarded to the department head for approval.
  • Once approved by Department Head, the same shall be routed for authorization to Head QA.
  • The original copy of the Guideline shall be initiated, approved and authorized with signature and date.
  • Review Procedure for Guideline:
  • Any changes desired and deemed necessary shall be initiated through a “Change control form”  (Refer Annexure 3) as per SOP on “Change control”.
  • Incase there is a change in the Format or Reference annexure only, the same shall be revised as per SOP “Change of Format / Reference annexure”.
  • Distribution and control of Guidelines:
  • The original copy of the Guideline shall have the original signatures and shall be maintained at Documentation cell (QA).
  • Issuance of Guideline shall be controlled by Documentation cell (QA). The details of issuance shall be entered in “ Issue record “ (Refer Annexure 4).
  • Documentation personnel (QA) shall provide the photocopy of the Guideline from the original copy to concerned departments.
  • Documentation personnel (QA) shall stamp as
  • Issued By:—————
  • Issued To: ————–
  • User Copy No: ——— on the top of the Guideline, sign with date and issue copy to concerned department/ section/area.
  • If need arises for an additional copy of Guideline, the concerned Head of the department or his designee shall make request to Documentation personnel (QA).
  • Documentation personnel (QA) shall arrange for the issue of a copy of the requested Guidelines.
  • The details of the issuance shall be recorded in Issue record. (Refer Annexure 4).
  • Photocopying of guideline is prohibited, unless a written permission is obtained from Head –QA or designee.
  • Any Guideline issued for non operational use shall be stamped as “ Uncontrolled Copy, Not for operational use” on every page with signature and date of Head QA or his designee.
  • For regulatory submissions, copies of the Guidelines shall be issued to Regulatory Department as such without stamping uncontrolled copy.
  • User copies of old and superseded Guidelines shall be returned back to Documentation cell (QA). Head-QA shall ensure reconciliation and destruction. The destruction details shall be entered in issue Record (Refer Annexure 4). The original copy of the superseded document shall be stamped as “Obsolete- for reference only” and stored.
  • DOCUMENTATION
  • Formats:
  • Specimen format of ‘Guidelines’- Annexure 1
  • Specimen format of ‘Change control form – Annexure 3
  • Specimen format of ‘Issue record’ – Annexure 4
  • Reference Annexure’s:
  • List of department codes – Annexure –2.

—————Document End—————

To Get the full sop and annexures in word format contact in contact Form:The cost of the SOP INR 500 Approx $ :-7.

OBJECTIVES:

  • To lay down the procedures for determination of significant figures and rounding rules for various calculations performed by all the operational departments like Analytical Development, Pharma Research, Quality Control, Production, Engineering, Warehouse and Quality Assurance etc.,

RESPONSIBILITY:

  • Personnel of concerned Department to implement.
  • Heads of concerned Department to ensure compliance.

PROCEDURE:

  • This procedure is applicable for all mathematical calculations involved in manufacturing, testing, packing, calibration, etc., where tolerance limits are specified.

Definitions

  • Rounding: Mathematical reduction of numerical values to the digit required according to the significant figure or tolerance established for the particular operation, method or process.
  • Significant figure: Number of digits in a decimal or whole number, to be considered as significant or representative of the real value, specification limit, or result for a particular method, operation or process.
  • Tolerance:  Acceptable range established for a particular method, operation or process expressed as lower and upper limit. When the tolerance are numerically expressed the same is considered as significant to the last digit shown. This is valid regardless of whether the values are expressed as percentages or absolute numbers.
  • Significant figure determination:

  • The significant figure for a numerical value is normally given by the tolerance limit,established for the particular method, operation or process under consideration.
  • If the tolerance limit is expressed in decimal places, the result obtained must also be expressed or documented in decimal places following the same number of decimal places. If no decimal place is allowed, no decimal place is reported.
  • If it is a set value having no tolerances, (as in the case of a weighing process for a raw materials) the process must be documented according to decimal places determined by the set value. The balance or any equipment used for the process must provide accuracy up to the last digit established by the current specifications.
  • In the case of testing methods, the significant figures are normally indicated by the methods itself. For analytical methods follow the significant figures established by the current specifications.
  • Rounding:
  • The following rules are followed whenever rounding is needed to reduce a numerical expression or value to the last significant digit.
  • Determine the number of significant digits to be used in reported result.
  • Truncate to one digit beyond the significant digit required.
  • If that digit is 0,1,2,3, or 4 then the previous digit remains as is
  • If that digit is 5,6,7,8 or 9 then the previous digit is increased by one.
  • In case any doubt on how to round a significant figure consult your immediate senior
  • Example Table:

    Specification: NMT 1.00

    Specification: NMT 10.0

    Specification: 300 – 400

    Calculated Result

    Rounded Off to

    Calculated Result

    Rounded Off to

    Calculated Result

    Rounded Off to

    0.950

    0.951

    0.952

    0.953

    0.954

    0.95

    15.90

    15.91

    15.92

    15.93

    15.94

    15.9

    320.00

    320.10

    320.20

    320.30

    320.40

    320

    0.955

    0.956

    0.957

    0.958

    0.959

    0.96

    15.95

    15.96

    15.97

    15.98

    15.99

    16.0

    320.50

    320.60

    320.70

    320.80

    320.90

    321

  • Exceptions :
  • In case of reporting of impurities, rounding off shall be done as described below in the below mentioned specific cases.
  • When the specification is a whole number without any decimal and the calculated value is less than 0.5% result shall be reported to one decimal after rounding off.
  • e.g.,   

Parameter

Specification (%)

Calculated Value (%)

Shall be reported as (%)

Total Impurities

2

0.846

1

Maximum Individual Impurities

1

0.441

0.4

  • When the specification is in one decimal and the calculated value is less than 0.1%, result shall be reported to two decimal after rounding off.
  • e.g.,

Parameter

Specification (%)

Calculated Value (%)

Shall be reported as (%)

Total Impurities

0.2

0.045

0.05

Maximum Individual Impurities

0.4

0.064

0.06

Any other Individual Impurities

0.4

0.003

0.00

  • For calculating the assay on anhydrous basis, moisture content / LOD shall be taken in 3 decimals without rounding the calculated value, irrespective of the no of significant figures present in the specification.
  • e.g.

Parameter

Specification (%)

Calculated Value (%)

Shall be reported as (%)

Value for assay Calculation (%)

Water Content

2.0

1.3496

1.3

1.349

Loss on Drying

1.0

0.2456

0.2

0.245

  • DOCUMENTATION:
  • Formats: Nil.
  • Reference Annexure’s: Nil.

—————Document End—————

To Get the full sop and annexures in word format contact in contact Form:The cost of the SOP INR 350 Approx $ :-5.

OBJECTIVE:

  • To lay down the procedure to evaluate the effect on physical condition, temperature on consignments during transport.

SCOPE:

  • This procedure is applicable to products that are dispatched by Air, Sea and Road.

RESPONSIBILITY:                                                            

  • Warehouse to get the necessary permissions for usage of data loggers in the study.
  • SCM/Planning to communicate and arrange for retrieval of data loggers placed in the packed shippers /packs from the customer source.
  • Quality Control to analyze the sample
  • Quality Assurance to provide the formats, arranging for data logger with calibration status, positioning of data logger and receiving the data logger with samples and ensure the compliance.

DEFINITION(s)

  • Not Applicable

PROCEDURE: 

  • Identify the product consignment/Batch number that needs to be evaluated for transport worthiness study by preparing a schedule.
  • Ensure that calibrated data loggers are used, so as to get the record of temperature at a frequency of every four hours throughout the transit period.
  • Warehouse shall arrange to get the necessary permission for keeping the data loggers inside the packed shippers or containers.
  • Enter the details of Product/ B.No. /Location of data loggers in the Transport Worthiness Study.
  • Place the data data logger in a manner so that it is on the outermost layer of the pallet on which the packs are placed. In Remark column of the Annexure write the shipper number in which the data logger has kept, and kept the filled format inside the shipper.
  • Label the shipper /pack as ‘Data loggers kept inside’ for identification.
  • Get the shippers/packs palletized and stretch wrapped.
  • Send the scanned copy of filled Transport Worthiness Study form through the e-mail to the customer on the receipt of consignment, page no: 2 of 3 on Annexure shall be filled by customer or Telephonic discussion can be acceptable in case of page 2 of 2 is not filled and same can be mentioned in the remarks.
  • SCM shall communicate to the customer, the details of consignment in which data loggers are placed.
  • On receipt of consignment at customer end, arrange to get the relevant part of the Transport Worthiness study form filled by the customer.
  • Arrange to withdraw the required quantity of sample at customer end as detailed in   the Form. Sampling shall be carried out so as to cover all layers of the packs (Top, middle and bottom layer)
  • Sample along with data loggers shall be sent back to sending unit by the fastest courier and analyzed according to indicated specification.
  • Where a facility for testing is available, the testing shall be carried out at customer end. In such case only data logger shall be forwarded back to the sending unit.
  • In case of sample has not located due to customs clearance Temperature data only to be reviewed and summary / conclusion can be drawn.
  • On receipt of data loggers from the customer, download the temperature data and carryout the tests on samples as mentioned in the stability specification. (as applicable).
  • Evaluate the results in correlation with the analytical data of customer sample analysis and supplier analysis report.
  • Draw the conclusion on the transport worthiness based on the testing, temperature data and physical condition on receipt report.
  • Record the results and summary in the Transport Worthiness study form and get it certified by SCM, QC and QA
  • If the particular product is validated for Transport Worthiness for three seasons, the same product shall be stopped for monitoring in the next cycle.
  • If there is any change in the mode of transport, the study shall be repeated using   the new mode of transport.

REFERENCE(s)

  • Not applicable

—————Document End—————

To Get the full sop and annexures in word format contact in contact Form:The cost of the SOP INR 500 Approx $ :-7.

OBJECTIVE :

  • To establish responsibilities and guidelines for proper handling of inspections by External Agency (Like USFDA, UK-MHRA, TPD-CANADA, TGA-AUSTRALIA etc) /Customers.

RESPONSIBILITY : 

  • The Regulatory Affairs Department is responsible for communicating the inspection schedule to various departments in the plant and to receive the Inspectors  from  external Agency.
  • The Quality Assurance Personnel / Company Representative is responsible to facilitate the inspection in the plant.

PROCEDURE :

General preparation for Inspection:

Prior to an inspection taking place it is important to organize the following:

a) The name of the inspector and the scope of the inspection and all dates agreed in  advance

b) Who shall be along with the main facilitator during Inspection?

c) A room for the Inspector (s) for reviewing all the documents requested

d) Are the photocopying facilities ready?

e) All the refreshments shall be arranged provided should not be viewed as enticement.

f) Inspection training for staff shall be imparted( if required) to prepare for an  inspection.

g) Ensure that all the staff are familiar with their location and responsibility.

h) Ensure that all the documents that are to be requested are immediately retrievable

Receiving the Inspector:

  • Properly credentialed Inspector bearing a notice of inspection shall be allowed into the plant by the security staff. Inspectors shall sign in the visitor’s register. 
  • Security Person / Receptionist shall direct the inspector to a comfortable area and contact company representative.
  • The RA Personnel shall accept the written notice of inspection from the inspector, in appropriate form.
  • The QA Personnel / Company Representative shall determine the purpose and the extent of the investigation and initiate the required activities to satisfy the need.

Handling the Inspection:

  • The QA Personnel / Company Representative shall document the minutes of the inspectors investigation points during the inspection and periodically communicate to the management. The QA Personnel / Company Representative shall always accompany the inspector during the inspection.
  • The inspector questions shall be answered honestly and completely without speculation. If one do not know the answer, make note of the question and get back to the inspector with proper answer.
  • If the Inspector needs to see records, determine exactly what is required and supply the records / information as appropriate.  
  • If copies of records are required, photocopy with “Uncontrolled copy not for operational use” stamp, duly signed by QA personnel shall be issued and same shall be recorded in the format ” List of documents Issued to External agency” (Annexure).
  • During the inspection QA Personnel / Company Representative shall ensure that responsible and knowledgeable persons are present during the inspection, who can give accurate answers to questions.
  • The company policy on prohibition of taking photographs shall be informed to the inspectors.
  • At the end of each working day, request the Inspectors to discuss with you any concerns they may have developed during the course of their inspection.
  • QA Personnel / Company Representative shall make a detailed report of all activities for the day and discuss in meetings with all Head’s of Departments.

Wrap up Inspection:

  • When the inspection is complete, QA Personnel / Company Representative shall return with the Inspector to the conference area for an exit interview.
  • Accept the Inspection Report from the Inspector , if one is given and discuss the findings with the Inspector.
  • If there is disagreement with any of the findings, point the matter out to the Inspector with a view to having it removed or corrected, but do not be argumentative.

Close out of Investigation:

  • As soon as possible after the inspection / investigation, QA Personnel / Company Representative shall convene a meeting with the persons responsible for taking corrective action on the alleged deficiencies.
  • Quality Assurance Department shall coordinate and prepare appropriate responses with a timetable for corrective action.
  • Regulatory affairs / QA department shall submit written responses to the respective agencies / customers and also ensure that the required corrective actions are implemented.
  • Head QA shall share the Inspectional observations given by external agency to the Head QA .
  • A copy of response documents shall be sent to Global compliance.

Retention Samples :

  • If Inspectors of External Agency request product samples, Quality Assurance shall arrange to provide and retain duplicate sample amounts of those provided.
  • Head QA shall also ensure that deficiencies raised at other locations are received, reviewed and implemented as appropriate.

—————Document End—————

To Get the full sop and annexures in word format contact in contact Form:The cost of the SOP INR 500 Approx $ :-7.

OBJECTIVE:

  • To provide a procedure for preparation and approval of sampling protocols for submission batches.

RESPONSIBILITY :

  • Pharma Research for preparation of sampling Protocols.
  • Quality Assurance personnel to review and execute the protocol
  • Quality Control to Analyse the samples and generate the reports.
  • Heads of Pharma Research , Quality Control and Quality Assurance or their designees to approve and certify the protocols.

PROCEDURE :

  • Sampling protocol shall be prepared by Pharma Research.
  • Sampling Protocol shall contain the following details 
  • Objective
  • Responsibility
  • Sampling Procedure
  • Equipment layout indicating the sampling locations, if any.
  • Certification page
  • Pharma Research personnel after preparing protocol shall forward the same to Head- Pharma Research.
  • Head -Pharma Research shall approve the protocol, if found satisfactory and forward the same to Head-QC.
  • Head-QC shall approve the same and forward it to Head-QA
  • Head -QA shall approve the protocol and hand it over to QA personnel for execution
  • Once the protocol is executed, documents like copy of Analysis report related to that particular product shall be enclosed and send for certification to Head-Pharma Research.
  • Heads of Pharma Research, Quality Control and Quality Assurance shall review the results and certifiy the sampling protocol.
  • Numbering of Sampling Protocols 
  • All the sampling protocol’s shall be identified with unique numbering system.
  • Sampling protocol number consists of eight characters
  • The first character is “SM” denotes sampling protocol.
  • The next two characters are “EB” indicating exhibit batch.
  • The fourth character is “-” (dash).
  • The last three characters are numerical denoting the serial number starting from “001” for each nature of batch.

         Eg: The first sampling protocol prepared for Exhibit batch shall be                                   numbered as”SMEB-001″

  • The sampling protocol number and other details shall be entered in the “Control Register for Sampling Protocol” (Annexure) and shall be maintained by Pharma Research

DOCUMENTATION: 

Formats:

Specimen format of “Control Register for Sampling Protocol” – Annexure 

—————Document End—————

To Get the full sop and annexures in word format contact in contact Form:The cost of the SOP INR 500 Approx $ :-7.

OBJECTIVE :

  • To provide guideline for Review and Implementation of Corporate Policies /Procedures at site.

RESPONSIBILITY :

  • Corporate to issue document (Policy/Procedure) to impacted sites.
  • QA personnel to co-ordinate with respective departments at site for impact / gap assessment and subsequent implementation as applicable.
  • Concerned Head of the department for performing review, impact / gap assessment against the site Procedure and revision of the site procedure as appropriate.
  • Head – Quality Assurance to ensure compliance.

PROCEDURE :

  • Corporate Policies / Procedures, created / revised if and when having impact on other sites shall be sent to respective sites by the corporate – Quality Compliance.
  • Upon receipt of Corporate Policy / Procedure, QA personnel shall identify the relevant department / site procedure which may be impacted. 
  • Based on the scope and functionality of the document, QA personnel shall identify and forward the Corporate Policy / Procedure to the concerned departments at the site for performing Impact / Gap assessment.
  • Concerned Head of the department shall evaluate the impact of the Corporate Policy / Procedure on the site systems & procedures and perform Gap assessment.
  • All the impacted documents shall be appropriately revised to be inline with the intent of the corporate document through “Change Control” procedure and implemented within the effective date of the Corporate Policy / Procedure (i.e : 45 days from the Issue date of the Corporate document).
  • Impacted documents and its implementation details shall be recorded in “Policy/Procedure Implementation form” (as referred in corporate procedure and sent across to Quality Compliance Mail Box by QA personnel with in 45 days from the issue date of the Corporate document.
  • If there is no impact on the site documents, the same shall be indicated in “Policy/Procedure Implementation form” (as referred in corporate procedure) with precise justification and sent across to Quality Compliance Mail Box.
  • When the implementation is not possible before the established effective date of the corporate document, an extension plan shall be prepared including, specific implementation plan & implementation date with clear justification for the extension in “Extension plan for Implementation of Corporate Document” (as referred in Corporate procedure).
  • A copy of the approved extension plan shall be sent to Quality compliance mailbox and maintained at the site.
  • Post implementation details shall also be sent to Quality Compliance mail box by completing the respective table in “Extension plan for Implementation of Corporate Document” (as referred in Corporate procedure).

—————Document End—————

To Get the full sop and annexures in word format contact in contact Form:The cost of the SOP INR 250 Approx $ :-4.

OBJECTIVE:

  • To lay down the procedure for review of Analytical documents.

RESPONSIBILITY:

  • Quality Assurance personnel to review the analytical documents for adequacy and completeness.
  • Head-QA or his designee to ensure the compliance.

PROCEDURE:

  • Review of Analytical documents:
  • Analytical documents for Raw materials, Packaging materials, In-Process, Finished product, Stability samples, Analytical method transfer and Analytical method validation shall be reviewed for adequacy and completeness with respect to but not limited to the following:
  • All tests are performed and results are meeting the specifications.The test method,SOP and specification used to perform the testing is appropriate and current.
  • Manufactured by, A.R.No., B.No., Mfg. Date, Exp. Date, Batch quantity etc details are complete in Analysis Report as per analysis request.
  • A.R.No. is same on all the pages of Record of analysis.
  • Record of analysis is complete without any blanks for TS Lot No.’s, Equipment ID No.’s, Passes / Fails, Media Lot No.’s, working standard / Reference standard,Use before dates wherever applicable.
  • Check the Microbiological medias or diluents, Chemical Reagents, TS / mobile phase, Standards, Standard solution and Sample solutions used are within their establshed solution stability periods or expiry dates.
  • Any manual measurements done e.g., TLC should be checked.
  • Temperature, time and pressure values are specified in STP. Correct equipment parameters mentioned in record of analysis. All balance / instruments /equipment print-outs, chromatograms are signed with date.
  • Incase of chromatographic Analysis, check and confirm the system suitability test results are within specified requirements to ensure that instruments is suitable for use.
  • In case of Microbiological analysis, check all entries, completeness of records, dates of incubations. For Bacterial Endotoxin Tests check the Maximum valid dilutions in line with specification limits and incubation times [start time and end time] For sterility tests check the number of units used, number of rinses followed and type rinse fluid used for Sterility tests.
  • Ensure that integration is consistent across the sequence for chromatographic tests.
  • Check for correctness of reference of record of analysis given for system suitability, bracketing standard calculation etc.
  • Calculations shall be checked at random. Correct data transfer from all the printouts.
  • All details available on analysis request and Results from record of analysis are ‘correctly entered in analysis report. Analysis report is checked and approved.
  • Verify neatness, legibility of all records, including correctness for cross outs,overwriting and any other mistakes. Any documentation error is signed and dated as per the SOP ” Good Documentation Practices and Rectification of Documentation Errors” .
  • Check the availability of photo copy of instrument / equipment outputs printed on thermal paper if any.
  • In case of particulate matter analysis, check the diluent and volume of diluent used for dilutions. For sub visible particulate contamination tests, check the correctness of AR number and values per unit or per gm or per dose in case of multiple dose parenteral products on LPC printouts.
  • Rounding off significant figures are followed as per the SOP ” Determination of significant figures and rounding rules”.
  • Each test is signed and dated by analyst and checked, signed and dated by second person.
  • Any Incidents / OOS / Deviations reports filed are complete i.e. Disposed / Authorized / Approved as per SOP ” Deviations and Incidents” (QA023) & “Investigation of Out of specification results in QC laboratory”.
  • In case of Raw material and Packing material record of analysis, check for the manufactures COA and compare results with manufacture COA.
  • Compare the analytical data of stability (data) samples with previous analytical data,abnormalities if any shall be addressed immediately.
  • Check that the analytical method validation is done as per the parameters mentioned in the approved protocol and same data is transferred in summary report.
  • Check that the analytical method transfer is done as per the test methods mentioned in the approved protocol, and as per test method all necessary instructions to be followed during method transfer and the same shall be reported in protocol.
  • If any specific document(‘s) are not received, incomplete or incorrect, the same shall be notified to the concerned personnel responsible and the head of the respective department for appropriate action.
  • After reviewing the documents, QA personeel shall put a tick [ √ ] mark in green color next to the results, to ensure that results are within the specified limits. 

—————Document End—————

To Get the full sop and annexures in word format contact in contact Form:The cost of the SOP INR 280 Approx $ :-4.

OBJECTIVE :

  • To provide a procedure for verifying the preparedness with respect to documents,training status etc., before starting the exhibit batch.

RESPONSIBILITY :

  • Pharma Research, Analytical Development,Quality Control,and Validation to submit all the related documents to Quality Assurance.
  • Quality Assurance personnel to verify the documents.
  • Heads of Pharma Research, Analytical Development, Quality Control, Validation and Quality Assurance to ensure compliance. 

PROCEDURE :

The following documents shall be submitted to QA by Pharma Research :

  • Product Development Report.
  • Master manufacturing record and Master packing record
  • Sampling protocol
  • Development data and technology presented,ect.,

The following documents shall be submitted to QA by Analytical Development:

  • Analytical Method Validation Protocols and summary reports.
  • Specifications and Standard Test Procedures for all Raw materials,Packing materials,Inprocess and Finished product,etc., 

The following documents shall be submitted to QA by Quality Control:

  • Analytical documents of all materials.
  • Method transfer protocols,etc.,

The following documents shall be submitted by Validation to Quality Assurance :

  • Cleaning validation protocols,ect.,

The following documents shall be submitted by Quality Assurance :

  • Stability protocol,etc.,
  • Quality Assurance (Training) shall verify the training status of persons to be involved in the exhibit batch.
  • Warehouse to verify the availability of required materials for the batch.
  • Quality Assurance shall verify the availability of documents and materials and fill in the “Checklist for preparedness for Exhibit batch”(annexure).

DOCUMENTATION :

Formats :

  • Specimen format of “Checklist for Preparedness for Exhibit batch”-Annexure 

Reference Annexure’s: Nil.

—————Document End—————

To Get the full sop and annexures in word format contact in contact Form:The cost of the SOP INR 400 Approx $ :-5.

OBJECTIVE :

  • To provide a procedure for reviewing all the executed documents like Record of analysis, Analytical Method Validation protocols, Batch manufacturing records,batch packing records etc.

RESPONSIBILITY :

  • QA personnel for reviewing the executed documents.
  • Head QA or his designee to ensure compliance.

PROCEDURE :

  • Once the documents like record of analysis, Analytical Method Validation protocols, Batch manufacturing records etc., are executed, the same shall be submitted to QA for review.
  • QA personnel shall review the documents for the following, but not limited to.
  • Conformance of the results to the specifications.
  • Comparison of the raw material results against the manufacturer’s COA.
  • Reporting system of analytical results.
  • Checking the process parameters like mixing/blending time, drying time & temperature, sterilization parameters, compression parameters, coating parameters, filling parameters etc.,
  • Checking the balance print outs.
  • Checking the yield and reconciliation at all stages of manufacturing.etc.,
  • After reviewing the documents, QA personnel shall put a tick [ü] mark next to the results, to ensure that results are within the specified limits.

—————Document End—————

To Get the full sop and annexures in word format contact in contact Form:The cost of the SOP INR 250 Approx $ 4 .

OBJECTIVE:

  • To lay down the procedure for Quality Improvement Program (QIP) initiation, evaluation and implementation.

SCOPE:

  • This procedure is applicable to all the products of Pharma Advise
  • Where repeated observations or failures (to meet product specifications) are reported.
  • Any improvement or additional requirements suggested by marketing  group based on their feedback.
  • As a feedback from Technical Market Surveillance (Tech-Mar)study.
  • As a part of cost improvement program.
  • As a stability study feedback and recommendations thereon.
  • As a market complaint investigation feedback

RESPONSIBILITY

  • CQA shall coordinate and monitor the QIP improvements.
  • Plant QA shall evaluate the recommendation of Quality Improvement with concern heads and update regularly to CQA.
  • Production / TTG or concerned department Head / Plant QA shall monitor QIP work at Plant for Quality Improvement Program.
  • IPD/DQA/DH shall evaluate and initiate the improvement program based on the issues or concerns identified, at plant level and inform action plan of implementation to CQA.

DEFINITION(s)

  • Quality Improvement : Any change / modification in existing product to improve its quality with respect to pharmaceutics,  pharmacokinetics, or pharmaceutical analysis.  

PROCEDURE

  • Any of concerned department i.e. Plant production, QA, Marketing, or Management, may inform to CQA, for QIP.
  • CQA shall issue the format Annexure –1 for QIP.
  • CQA shall register the QIP request in plant wise register in Annexure – 2. and forward the QIP request to concerned plant, for example(Plant no)QIP/XXXX/01,Plant No 
  • eg. FM1, FM2….. etc.
  • XXXX will be the year, and 
  • 01 will be the serial no. in year. 
  • Plant Head / TTG shall evaluate the product based on trend data or feedback received for the product along with Plant QA and complete the format.
  • Plant QA shall inform back to CQA for the status of acceptance of proposal within 10  working days or after initial verification of  product/ proposal as the case may be.
  • If, necessary, TTG shall work out their action plans to rectify  the problem.
  • If, the issue is not being addressed and repeated failures or observations are made, Plant Production / TTG / QA  shall make a proposal  with detailed investigation report  and shall forward to  CQA for evaluation.
  • Plant QA shall evaluate the quality of product with Quality Head, for the degree of impact on Quality, Safety and Efficacy and need for future action plan. If the impact don’t related to critical quality issues, the routine production may be continued till the QIP takes place.
  • CQA shall evaluate the proposal and investigation details, and the proposal shall be forward to IPD group for QIP.
  • IPD group shall review and evaluate the proposal with DQA and if any further feedback from plant is required, shall coordinate with Plant QA. 
  • IPD shall make action plan and carry out experiments or trial batches keeping in view of the regulatory and filing requirement to respective market or countries.
  • IPD shall inform CQA for development activity and Quality Review  Management Meeting  with tentative time-lines for development, testing and technology transfer to Plant.
  • The action plans shall be critically reviewed every month as a part of Quality Review Management meeting, to see the impact on the deliveries and inventory control where necessary.
  • Upon the successful completion of action plan, the revised process shall be transferred to plant production through Technology transfer process.

REFERENCE(s)

  • Not Applicable

ABBREVIATION(s)

Abbreviation

Full Description

CQA

Central Quality Assurance

DH

Delivery  Heads

DQA

Developmental Quality Assurance.

IPD

Integrated Product Development Department

QA

Quality Assurance

QIP

Quality Improvement Program

QRM

Quality Review Management meeting

TTG

Technology Transfer Group.

—————Document End—————

To Get the full sop and annexures in word format contact in contact Form:The cost of the SOP INR 1000 Approx $ :-14.

OBJECTIVE :

  • To lay down a procedure for training of personnel associated with manufacturing, packing, holding and distribution of drug products.

SCOPE:

  • This procedure is applicable for all operations of  Pharma advise.

RESPONSIBILITY:

  • Responsibilities of individual(s) / concerned departments are as follows:
  • Induction training: HRD, Intimate, Department leaders and Training In-charge.
  • On-the-Job training and Safety training: Department leaders and HOD.
  • cGMP training / Refresher cGMP training: Training Incharge.
  • Refresher training / Re-qualification (SOP training): Department leaders and HOD.
  • Snap Test: Training In charge
  • Training needs identification: Training In charge & HOD
  • Retraining (Remedial training): Training In charge & HOD
  • External training and specific training: HOD
  • Trainee shall be responsible for attending the training, report writing and entering in the Training Log Book and keep up-to-date the Employee Training Card for self.
  • Head of Quality Assurance and concerned HOD for the compliance / implementation of this SOP.

DEFINITION(s)

  • Induction Training: which includes an overview of organization, business unit and parent department. All employees including management trainees shall undergo induction training.
  • cGMP Training : which includes various chapters covered as per different regulatory guidelines for cGMP. All employees who are directly associated with the manufacturing, packaging, holding and distribution process shall undergo such training.
  • Technical Training: is designed to develop specific functional / cross functional skills and update the technical knowledge.
  • Department leaders: A person (at Grade B/Grade C level or above) designated in each department who shall facilitate the training for the new joinee in to the department.
  • Intimate: A person from new joinee’s parent department (either at the same or higher level than new joinee) who shall facilitate departmental orientation to the new joinee.

PROCEDURE

  • Induction Training
  • Induction training program shall be organized, so that new / transferred employee is introduced with the interacting departments, staff members and gets familiarized with the overview of organization, unit and department.
  • HRD along with the concerned Department leaders shall prepare the induction schedule in consultation with the Plant Training In-charge / concerned HOD and record the details in the Induction Training Schedule. 
  • A Intimate shall be identified at the parent department and a copy of induction schedule shall be given to the new recruit and Intimate.
  • New recruit shall be introduced by HRD to his / her Intimate, who is responsible to help the new recruit through the induction period and beyond.
  • The general flow of induction training program (Induction Overview) shall be as follows:
  • Overview of the Organization and Unit: Philosophy, Structure, Policies, Rules and Regulations, Plant Entry and Exit Policy and Safety, Health and Environment Policy.
  • Overview of the other interacting department, ‘Customer’ and ‘Supplier’ departments, to familiarize with staff and understand the organigram, sections and basic processes and interdependence in relation to his/her job responsibilities.
  • Overview of the parent department to familiarize with staff and understand the organograms, sections and basic processes and interdependence in relation to his/her job responsibilities.
  • At the end of the induction training new recruit shall prepare a brief report of the activities seen and shall list any suggestions if any and forward the report to the parent department HOD for evaluation.
  • The concerned parent department HOD or his designee shall evaluate the report and shall take appropriate action(s) based on the suggestion(s) / recommendation(s) made by the new recruit.
  • On –the- Job Training
  • On the job training shall include the in-depth training in the parent department and cross-functional department of the new employee.
  • HOD shall prepare the detailed schedule for the On-the-Job Training based on the assigned job responsibilities and record the details in the ‘On-the-Job Training Schedule for New Joinee’.
  • On the job training program shall include the training related to the specific aspects of an individual’s role including use of equipment, unit operations, safety norms to be followed, adherence to cGMP, assigned responsibilities etc.
  • The mode of imparting training shall be through a combination of one or more of the following: reading procedures, presentation, practical training, discussion and questionnaire.
  • After successful completion of the On-the-Job training, trainee is issued a certificate duly signed by concerned HOD and Plant QA In-charge / Plant Training and Development In-charge.
  • If a person is transferred from one department to another, the training           In-charge shall be informed.
  • A separate On-the–Job training shall be initiated by the head of the new department.
  • cGMP Training
  • This program shall be mandatory for all employees (New and Existing) and shall cover the r requirements of the countries being catered.
  • cGMP Training for new joinees
  • This program covers all new employees for the manufacturing, processing, packing or distribution.
  • Employees shall be categorized into 2 groups for cGMP training program.
  • Group – I comprises of employees with Pharmaceutical background either in education or experience.
  • Group – II comprises of employees without Pharmaceutical background either in education or experience.
  • This program shall cover basics of cGMP and conducted as classroom training.
  • cGMP Training for existing employees (Refresher program)
  • This training shall be classroom training conducted once in 4 months covering cGMP requirements. Training schedule shall be prepared by Training In charge.
  • For refresher cGMP Training programs employees shall be divided into 2 groups.
  • Group-I comprises of Production Associates, Technical Associates, Workmen & other operating staff.
  • Group-II comprises of Technical Officers, Chemists, Officers, Executives and above.
  • The program shall include the various regulatory guidelines.
  • cGMP programme for a calendar year shall be prepared by Training and Development incharge.
  • Refresher Training / Requalification (SOP)
  • Regular training updates to personnel on key aspects on their role shall be chosen and training conducted.
  • All employees shall undergo Refresher training / Requalification on the procedures of their respective functions and related process or cross functional department wherever applicable.
  • Each department shall prepare a schedule for SOP training by means of matrix to cover training of all related activities.
  • Refresher training / Requalification shall be carried out once in a year and whenever there is a procedural change or revision before implementation.
  • Snap Test
  • Snap test shall be conducted to check the awareness and adherence to the systems and procedures.
  • Snap test shall be a surprise test conducted by Training In charge in various departments on procedures / systems.
  • Frequency: Once in every year for all trained personnel available as on date of snap test or as and when decided by Plant QA Incharge.
  • Training needs identification
  • Specific Training Programme
  • Training In charge and concerned HOD shall identify the training needs with the help of following training indicators, but not limited to:
  • Outcome of the compliance monitoring and any noncompliance raised by the internal and external audits.
  • Incident reporting system (Nonconformance)/ OOS/Deviation, Change Controls.
  • Market complaints.
  • Any mistake committed by personnel.
  • Repeated failures.
  • Audit findings.
  • Product recalls.
  • Based on the training needs identification, Training In charge and concerned HOD shall prepare the Training schedule at the beginning of the year.
  • In case of market complaints, incidents, deviations or OOS, the concerned Department Head shall prepare a specifically designed training programme.
  • Based on the event all the concerned personnel who are likely to be involved in performing the activity shall be listed and the details shall be recorded in the Training Needs Identification format.
  • Training shall be imparted to all concerned personnel.
  • Technical Training
  • Training In charge and concerned HOD shall identify the training needs with the help of following training indicators, but not limited to:
  • Various guidelines and regulatory requirements Various guidance document released by regulatory agencies.
  • Outcome of the feedback and expectations from the personnel during the training programs.
  • Based on the training needs identification, Training In charge shall prepare the Training schedule in yearly basis.
  • Retraining Programme (Remedial Training)
  • Retraining shall be identified and imparted in the following circumstances:
  • Disqualification in the evaluation process of any training programme.
  • Any deficiency noticed during self-inspection, audit or performance review.
  • Revision of SOP and Operating Instructions.
  • Inspite repeated training personnel fail to meet the required standard, they should not be permitted to perform their duties.
  • External Training
  • External training program shall include the training conducted by external institution or training conducted by external faculty in the organisation.
  • The concerned HOD shall nominate the candidate for external training.
  • Evaluation and certification of training
  • Training shall be imparted through the QA approved training modules/materials.
  • Training modules shall be prepared as described in annexure.
  • Numbering system for Training modules / materials: This is an alphanumerical number consists of 8 characters.
  • For example, first training module of central Training and Development shall be numbered as FTCTM001.
  • The first 2 alphabetical characters ‘FT’ represent the Formulations.
  • The 3rd character can be either an alpha or numeric one.
  • For example: An alpha character ‘C’ representing name of the function for centralized or common procedures, ‘G’ representing Formulations’ Generics unit or a numerical character ‘1’ representing for Formulations Unit 1. The numeric series shall continue serially for subsequent plants.
  • Next two alpha characters ‘ TM ’ represent Training Module.
  • The last three characters denote the serial number starting with ‘001’ and continue serially in increments of one unit.
  • Effectiveness of the training programme shall be evaluated to ensure that it fulfils the intended requirements.
  • On completion of training program the Trainee shall be evaluated through a oral test, written test or a discussion or using workout sessions. Where necessary like in SOP training, to evaluate the understanding a questionnaire shall be used as detailed in the Assessment Record. 
  • Trainee shall prepare detail report on his/her understanding of the training programme in the format (Annexure for Induction Training Report, Annexure for On-the-Job Training Report and Annexure for Evaluation and Assessment Record for SOP, cGMP, Snap Test, Specific Training or Retraining).
  • Trainer shall review the training report to evaluate the understanding of trainee and certify the trainee.
  • Wherever, evaluation is done through questionnaires, the Trainee shall be certified, if he has scored minimum qualification mark, which shall be 80% of the total marks allotted to the questionnaires.
  • The trainee shall answer correctly all questions identified as compulsory.
  • If trainee fails to obtain the minimum qualification marks or incorrectly answer the compulsory questions, retraining (remedial) shall be conducted and the same shall be recorded in the Assessment Record.
  • Trainer shall do practical assessment during On-the-Job training and the same shall be recorded in the On-the-Job Training Report .
  • On completion of ‘External Training’ program, trainee shall submit a External Training Report (Annexure and also record in the Personal Training File / Employee training card, wherever applicable. Report shall be submitted with in three working days to training In-charge along with copy of material if any.
  • Train the trainer
  • Selection of the Trainer: Trainer shall have sufficient education, training, and experience, or any combination thereof, to train the subject for which they are retained.
  • Evaluation and Certification of the Trainer: On the basis of qualification, experience, communication skills, and expertise in the field, the trainer shall be evaluated and certified by Quality Assurance Head / Training In charge for conducting training.
  • Trainer may obtain feedback from course attendees in order to improve effectiveness of training skills and materials as detailed in annexure.
  • Documentation
  • All records pertaining to training of employee shall be maintained by the concerned ambassador and Training In charge.
  • Employee Training Card:
  • The employee training card shall be issued to each employee at the time of joining, by the training In-charge.
  • All the training as mentioned above, attended by the employee shall be entered in the Employee Training Card.
  • All the employees shall ensure that the card is updated after completion of any training programme.
  • New training card shall be collected from training in-charge after depositing the completed old card.
  • Training Log Book
  • For all internal training programmmes the trainees shall enter their attendance in the Training Log. 
  • The trainer shall enter the comments and summary on the training conducted. 
  • For departmental training, training logbook shall be maintained by concerned ambassador of the department. Training logbook for common training programme shall be maintained by Training In charge.
  • Personal Training File
  • At the time of joining, a training file shall be opened for each employee.
  • The bio-data, induction report, training cards, evaluation reports/questionnaires, post training report (for external training), certificates and any other training related document of an employee shall be filed in the Personal Training File.
  • All the training files shall be maintained by Training In charge.
  • All the training documents shall be retained for a period of five years after the date of resignation or retirement. After five years the documents shall be destroyed and entered in the Destruction Record. 
  • Training documents of transferred employee shall be shifted to the new location and maintained along with current records at new (transferred) location.
  • REFERENCE(s)
  • Not Applicable

—————Document End—————

To Get the full sop and annexures in word format contact in contact Form:The cost of the SOP INR 750 Approx $ :-11.

OBJECTIVE :

  • To lay down the procedure for handling the crisis situations to ensure the Safety, Identity, Strength, Purity and Quality of the drug product.

RESPONSIBILITY :

  • Crisis Management team shall be responsible to take charge of the situation.
  • The Crisis Administrator (Head of Location) shall review crisis situation and ensure compliance.

PROCEDURE :

  • Crisis : A crisis may be generally defined as any damaging event or critical situation  that is nonrecurring.
  • The crisis shall be divided in two categories.
  • (i) Probable crisis due to our operations could be:
  • a) Fire.
  • b) Explosion.
  • c) Gas Leakage.
  • d) Spillage of Hazardous chemicals.
  • (ii) Probable crisis due to natural calamities and External Factors:
  • a) Earthquake.
  • b) Storms.
  • c) Lightning strikes.
  • d) Bomb threat.
  • e) Plane crash inside the premises.
  • Crisis Situations may have negative impact on Safety, Identity, Strength, Purity and Quality of the drug product. 
  • Note : In case of any emergency situations, immediate actions shall be taken as per Emergency Response and Crisis Planning’ (ERCP) manual to control any serious injuries, loss of life, extensive damage to property or environment or serious disruption inside the Plant.
  • The Crisis Management team shall be comprising of the members as listed below :
  • 1) Head of Location.
  • 2) Head Quality Assurance.
  • 3) Head Production.
  • 4) Head Engineering.
  • 5) Head Quality Control.
  • 6) Head Microbiology.
  • The crisis Management team is responsible for
  • 1) Identification of exact nature of crisis,
  • 2) Establishing objectives,
  • 3) Conducting a baseline assessment,
  • 4) Evaluation of impact of the crisis on the products, and
  • 5) Devising action plans.
  • The crisis management team shall record the exact nature of crisis in “CrisiManagement Form” (Annexure – 1) and shall collect all the available information including all relevant immediate actions (which may have negative impact on the product, like AHU shut down, use of fire extinguishers) taken to control the emergency situation.
  • Crisis management team shall review all the available information and shall decide the possible impact of the crisis on drug product.
  • Crisis management team, with the help of personnel responsible for respective area / operation, shall assess the damage to the buildings, systems, documents,laboratory, electrical panels, HVAC systems, boilers etc.
  • Crisis management team collectively, shall evaluate the impact of the damages on the drug product processed, packed, analyzed and distributed, with respect to Safety Identity, Strength, Purity and Quality.  
  • The crisis management team shall arrange for analysis of the drug product, which may have negative impact of the crisis.
  • The analysis shall include but not limited to following:
  • – Extensive sampling.
  • – Physical evaluation.
  • – Chemical tests.
  • – Microbial tests.
  • – Sterility test, Endotoxin test etc.
  • A protocol shall be prepared for sampling and testing with proper justification for each sampling and testing.
  • Depending upon the crisis, cleaning , disinfections, sanitation or fumigation of area shall be done before the work starts.
  • Based on the evaluation necessary recommendations/actions shall be taken to resume the activities.
  • Recommendations on corrective and preventive actions shall be reviewed and its implementation shall be ensured.
  • Crisis management team shall document all the observations in “Crisis Management Form” (Annexure-1).
  • Once activity is over, Head Quality Assurance along with crisis management team shall review the effectiveness of corrective and preventive actions and decide on status of batches in-process during crisis.
  • Based on the nature of crisis, an issue elevation shall be initiated by Quality Assurance as per ” Issue elevation procedure for appropriate decision by Corporate Management”.
  • Final decision shall be taken by Head-QA on drug product release / rejection.
  • Note: Depending upon the nature of crisis, Head-Regulatory Affairs Department shall provide the information to concerned regulatory authorities.
  • DOCUMENTATION:
  • Formats :
  • Specimen format of “Crisis Management Form”- Annexure-1.
  • Reference : Annexure : Nil.

    —————Document End—————

    To Get the full sop and annexures in word format contact in contact Form:The cost of the SOP INR 500 Approx $ :-7

OBJECTIVE:

  • This procedure ensures that no changes are made in any approved manufacturing process, standard operating procedure, cleaning procedure, Master production and master packing records, Specifications, Test procedures, vendor of raw materials, and primary packaging materials, cGMP related equipment/facilities/utilities/computer systems, until the proposed changes are reviewed, approved and deemed by change control team.

RESPONSIBILITY:

  • Change control team consists of Head-QA , Head of respective Department who has proposed the change, and other heads of concerned Departments, which may be affected by the change.
  • Head – QA or his designee to ensure the compliance.

PROCEDURE:

  • Whenever a change becomes necessary or desirable the concerned personnel shall raise a “Change Control Form” (CCF) (Annexure-1)  & “Change control form – continuation sheet”(Annexure-5) outlining the changes proposed or required and reasons for the change. The supporting documents for the change like experiment data, regulatory requirements, change in pharmacopoeial requirements, stability data, existing/proposed copies, regulatory comments, list of documents / activities effected by the change etc., if any, shall be attached and forwarded to the Department head.
  • Note: Changes carried by `CCF’ may include, but not limited to the following:
  • Creation, Addition, Modification & Deletion of cGMP facilities or cGMP utilities.
  • Changes to master production, master packing records.
  • Changes to computer system used for cGMP purposes
  • Changes for an additional or alternate source of raw materials and primary packing materials.
  • Changes in packing materials
  • Change in Artworks related to labeling of products
  • Changes in process and / or equipment.
  • Changes in manufacturing process.
  • Changes in product color / shape and size.
  • Changes to specification.
  • Changes to specification.
  • Changes to SOP, Guideline and Cleaning procedure.
  • Changes to Test procedure and general test procedures.
  • Change in drawings
  • Batch size change / additional batch size.
  • Decommissioning / Relocation of major equipment
  • The initiator of the Change Control Form (CCF), shall mention the type of change required, the respective document reference, in case change proposed in an approved document, and shall briefly write the changes proposed (required) and shall mention reasons for changes in the respective column on the CCF and forward to Department Head.
  • The Department Head shall review and enter his comments under the column for Department Head and shall forward the CCF to Head-QA or his designee for his review and comments.
  • Head QA or his designee shall review the CCF and if found satisfactory approve the CCF. Once CCF is approved, a number shall be allocated to the form by entering the details of change required in the “Change Control form register” (Refer Annexure 3).
  • The “Change Control Form” number shall be comprising of 11 characters.
  • The first two characters are `CC’ denoting change control. 
  • The third and fourth characters are Department codes indicating from which Department CCF has been originated. The Department codes are given in Annexure – 2.
  • The fifth character is a `/’ (Slash).
  • The next three characters are serial number starts from 001 every year.
  • The 9th character is a `-‘ (dash)
  • The last two characters (10th and 11th) are number indicating the year. e.g.  The first change control form initiated in year 2020 by the Quality Control Department shall  be numbered a CCQC/001-20.
  • Head QA shall assess/identify all relevant documentation/activities impacted by the change,  required validation activities and document the same on CCF and shall forward the CCF with comments to other heads of the concerned Departments which may be affected by the change. Incase of inclusion of safety instructions, the CCF shall be forwarded to SH&E department
  • Head QA shall forward the change control form to Head – Regulatory Affairs Department where changes are likely to affect the regulatory submission (Refer Annexure 4 for guidelines)
  • Head QA shall also take approval on changes from customers wherever applicable.
  • The change control team shall review the CCF and decide on accepting or rejecting the form based on the comments received and appropriate regulation, industry practices and cGMP requirements/compliance.
  • The team members of change control shall evaluate the CCF with respect to aspects of Validation, Training, Regulatory approval and stability studies etc.
  • In case of disagreement on changes required, the change control team shall be unanimous in accepting or rejecting the change.
  • Once comments from all members of change control team are entered in CCF, same shall be forwarded to Head QA (change controller)
  • If any, additional changes are suggested by other department heads, Head QA shall ensure that same are agreed and approved by initiator department and other department heads.
  • Head QA (change controller) shall review the comments of team members and summarizes the `CCF’ and shall mention whether change is approved or rejected in the respective column of `CCF’.
  • The summary shall be entered in  the ‘change control form register’ under the column ‘Summarized by Change Controller’ and whether CCF is approved or rejected. (Refer annexure- 3)
  • Incase, any additional changes are required after approval of CCF, Supplement CCF shall be raised by the initiator in “Supplement Change Control Form” (Annexure-6) & “Change control form – continuation sheet”(Annexure-5) and it shall be forwarded to Head-QA for approval. Head-QA shall forward the same to other departments for their approval.
  • The initiator Department shall be informed about the status of CCF by change Controller. Implementation copy of the CCF shall be given to validation department incase of changes where validation activities are indicated. The copy shall be stamped as “For Implementation”.
  • The change controller shall co-ordinate with the initiator and other related Departments For completion of action identified by change control team to complete the same. (Like Validation, training, stability initiation etc).
  • After completing all the requirements, the change controller shall review the completion of proposed change and assign effective date for implementation.
  • Once all the above activities are completed, final disposition of the change control shall be done by Head QA (change controller).
  • The effective date shall be entered in “Change Control Form register” under column`Effective date of change’.
  • Approved and completed change control form along with supportive documents shall be filed in file for CCF and kept in QA Department. Completed change controls shall be retained as per the SOP “Storage, retrieval, control and retention of all completed documents”
  • DOCUMENTATION
  • Formats :
  • Form’- Annexure 1:-Specimen format of ‘Change Control.
  • Form register’- Annexure 3:- Specimen format of ‘Change Control.
  • Form–Continuation Sheet’-Annexure-5:-Specimen format of ‘Change Control
  • Form’-Annexure-6:-Specimen format of ‘Supplement Change Control Form’-Annexure-6
  • Reference Annexure’s:
  • Annexure-2:-List of Department codes.
  • Annexure-4:-General guidelines on the changes which require Head-Regulatory approval ‘.

—————Document End—————

To Get the full sop and annexures in word format contact in contact Form:The cost of the SOP INR 500 Approx $ :-7.

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