Quality Control

OBJECTIVE:

  • To lay down a procedure for the qualification of analyst.

SCOPE:

  • This procedure is applicable to the Quality Control Laboratory.

RESPONSIBILITY:

  • Analyst- Quality control is responsible for getting trained and qualified in different types of analysis.
  • Head-Quality control or the designee is responsible for compliance of SOP.

PROCEDURE:

  • All the analysts in Quality Control shall under go training and qualify on relevant Standard Operating Procedures. The trainee analysts who are not familiar with the analytical techniques shall undergo qualification on analytical techniques. The general analytical techniques along with acceptance criteria on which the analyst are to be trained are listed in Annexure. The analyst who is familiar with the analytical techniques was to be evaluated for their technical competency through the annexure.
  • The training on analytical techniques shall be carried out under the supervision of the senior executive or a analyst already trained on that technique, by following the STP / SOP and using already approved product / material analyzed by the senior analyst as test standard.
  • To qualify on the analytical techniques, the analyst shall perform the test. The results shall be comparable with the results already reported and meet the acceptance criteria as given in Annexure.
  • The results shall be recorded in personnel validation format as per SOP.
  • Trainer shall review and evaluate the data generated by the analyst. If the results are satisfactory as mentioned above, it can be concluded that the analyst is qualified to perform the particular technique.  In case of any discrepancy or abnormality observed, it can be investigated, counseled and by omitting the mistakes, training shall be repeated and again evaluated.
  • Wherever mentioned to compare the analyst results against to standards shall be                      considered those values obtained either from the corresponding method validation data or the results obtained from any of the senior analyst.
  • Evaluation of the training shall be initiated whenever necessary depends on the analysts under training.
  • Evaluation of training shall be done by conducting oral / written tests,demonstrations and presentations.

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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 training and a mechanism to evaluate a analyst on General Analytical techniques.

RESPONSIBILITY :

  • Personnel who are knowledgeable with the subject by virtue of their qualification and experience, to train the analyst as required.
  • Head-Quality Control or his designee to ensure compliance.

PROCEDURE :

  • All  the analyst undertaking  analysis shall undergo training and qualify on relevant Standard Operating Procedures (SOPs), Guidelines and General analytical techniques as required.
  • Prior to performing the analysis of a particular test , Head- Quality control or his designee shall  ensure that the analyst was trained on  General analytical techniques of that particular test.

  • The training on analytical techniques shall be carried out under the supervision of the  Head -Quality control or his designee or an analyst already trained on that technique, by following  the STP/GTP/SOP and using already approved product/material as a test sample.

  • To qualify on the analytical technique the analyst shall perform the test. The results shall be comparable with the results already reported and meet the acceptance criteria.

  • Training register and Training file shall be issued to the analyst. The training on general analytical technique shall be documented in the “Training register” and the supporting documents like printouts, Excel sheats, etc.. shall be filed in the training file.

  • The following details shall appear in the record.
  • OBJECTIVE
  • PROCEDURE
  • ACCEPTANCE CRITERIA
  • RESULTS
  • TRAINER’S COMMENTS.
  • Trainer shall review and evaluate the data generated by the analyst. If the results are satisfactory as mentioned above, it can be concluded that the analyst is qualified to perform the particular technique. In case of any discrepancy or abnormality observed, it can be investigated, counseled and by omitting the mistakes, if any,training shall be repeated and again evaluated.
  • Lectures on technical subjects shall be conducted by qualified in-house/external staff. The subject of training shall be summarized as an abstract and the trainees are required to sign for attendance. The details shall be entered in training log book (For Annexure refer TR001) and individual staff training card.
  • Evaluation of training shall be done by conducting oral / written tests,demonstrations and presentations.
  • Any General / Technical training on-campus or off-campus shall be entered in the individual staff training card.
  • For general development and training of employee shall follow the SOP “Employee Training Programme”.
  • The training register and Training file shall be issued and controlled as per the SOP on “Issue and control of registers and files.
  • Analyst (Whoever is applicable) shall be trained on Technical training as per Annexure, SOP training related to Equipment / Instruments of Quality control laboratory as per Annexure and Status of Qualification of Analyst shall be documented in “Register for analyst qualification/requalification status” Annexure .
  • Requalification of analyst shall be done once in Two years after the initial Qualification date.( Refer Annexure for the analytiacl Techniques which needs Requalification).Status of Requalification of Analyst shall be documented in “Register for analyst qualification/requalification status” Annexure.

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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 documentation of analytical data.

RESPONSIBILITY :

  • Quality Control personnel, whoever is performing the analysis.
  • Head Quality Control or his designee to ensure compliance.

PROCEDURE :

  • All data generated during laboratory testing, except those that are generated by automated data collection systems, shall be recorded directly and promptly with legible ink, in the Record of Analysis.
  • Documentation shall contain the following aspects, but not limited to that mentioned below :
  • Product/Material name, AR No., Batch No./Lot No., STP No.
  • A record of weight or measure of sample, standard and other component used, dilutions involved in preparation of the required solutions.
  • A record of the lot No., use before and potency (wherever applicable) of the reference standards / working standards / impurity standards used.
  • A record of the lot no. and use before (wherever applicable) of test solutions/volumetric solutions / pH buffer solution/HPLC mobile phase/microbiology media used. Concentration of volumetric solution shall also be documented.
  • A record of the identification number of equipment/instrument/column used .
  • Wherever specific parameters are prescribed for analysis a record of parameters set for the instrument/equipment.
  • A record of the manufacturers name, grade and lot/batch number of all the chemicals used.
  • Wherever applicable a record that the suitability of system / Reagent is verified as specified in the procedure.
  • A record of starting and completion time wherever specific duration of time and temperature is prescribed in the procedure (e.g., LOD, LOI etc.,)
  • All printouts obtained shall be identified with necessary details like AR No. etc., with initial and date.
  • A record of the observations made during the analysis wherever applicable.
  • A record of all calculations performed in connection with the test, including unit of measure.
  • The initial or signature of the person who performed the analysis and the date the test was performed. If the test is performed on multiple days, record of analysis shall be signed at the end of each day’s analysis.
  • The initial or signature of a second person checking the record for accuracy,completeness and compliance to relevant approved procedures.
  • Note: In case of qualitative analysis, second person checking shall be done immediately after verifying the observations.
  • In case of any errors in documentation, follow SOP ‘Rectification of documentation errors’.
  • Follow SOP ‘Determination of Significant figures and rounding rules’ wherever applicable.

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

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