ANNUAL PRODUCT REVIEW

SCOPE:

To offer guidance as to what information/detail should be included in an annual product review

PURPOSE

The purpose of this annual product review is to verify consistency of the process and to highlight any trends of the product.

DEFINITIONS

Annual Product Review: A review, performed at least once a year, to assess the state of quality of each product and thereby determine any needs for corrective action. This report will provide valuable information for improvement of manufacturing quality.

RESPONSIBILITIES

It is the responsibility of the:Quality Control Pharmacist assigned the task to compile the data to be included in the annual product review, to compile deviations and in-process out-of-specifications and batch rejections, and to perform the relevant review of all batches of the products manufactured in the previous year.

Quality Control Department Manager to review the reports generated and put forward recommendations to correct any negative trends.

Quality Control Officer to assist in the collection of data to be included in the review reports.

Quality Assurance delegate to provide change control, complaint and recall data for all products to be reviewed in an Annual Product Review.

Analytical Services representative to collect raw material data, stability data and analytical out-of-specifications specific to each product reviewed.

Quality Control Pharmacist to follow-up and ensure that outstanding recommendations are closed off.

SAFETY CONSIDERATIONS

N/a.

PROCEDURE

Identify a team which will collect the data, analyse it and compile the Annual Product Review. The team shall be composed of representatives from: Quality Control

              Quality Assurance

              Analytical Services.

Additional representatives from other departments may be required to attend on an ad hoc basis.

Select a product.

Generate a report from XAL of all the batches, manufactured for the selected product, during the previous year.

Request the associated batch documents and retrieve the following information:

Finished product results (these may be obtained from the ‘Certificate of Analysis’).

Access the relevant data bases and retrieve all relevant information about deviations, out of specifications, change controls, sorting.

Request the responsible department for information regarding batch rejections, stability studies, recalls, complaints and validation status of processes and equipment/utilities.

Commence the compilation of the annual product review report, that must include at least the following sub-sections:

Period evaluated

Number of manufactured batches

Product description

Finished product analytical data

A review of raw material used in the product manufacture.

Sorting

Deviations

Out of specifications

Complaints

Rejections

Change controls

Recalls

Stability

Validation:In this case, a statement from the Validation Department Manager confirming that both process and equipment/utilities are validated.

A statement confirming that a review of the Marketing Authorisation variations and post-marketing commitments has been made available by Actavis Corporate.

Discussion: This should include an analysis of the data, identification of trends that may highlight  problems, areas where process control needs to be improved. A follow-up of recommendations made in the previous year should also be given where applicable.

Recommendations: These are based on the data and data analysis, for the improvement of product and/or process.

Repeat steps 3 to 7 for the remaining products, until all products/batches manufactured in the previous year are reviewed.

Approval: Forward the compiled annual product review report to the QC Department Manager for evaluation & review. In addition, the following individuals shall also review and sign the report:

Production Department Manager

Managing Director

Follow-up the APR recommendations and ensure that they are closed off in a timely manner.

REFERENCES

N/a.

APPENDICES

N/a.