1.0 PURPOSE
To lay down the procedure for Annual Product Review.
2.0 SCOPE
2.1 This SOP is applicable in Quality Assurance.
3.0 RESPONSIBILITY
3.1 Quality Control
3.2 Quality Assurance
4.0 ACCOUNTABILITY
4.1 Manager - QA & RA
5.0 PROCEDURE
5.1 Annual product review shall be carried out for each product manufactured inthe previous calendar year. Along with Annual product review, implementation of preceding year’s recommendations shall be reviewed.
5.2 Annual Product Review report shall be completed by the month of February.
5.3 Annual Product review should be essentially include the following:
5.3.1 Trend analysis for the following parameters shall be compiled essentially product wise and batch wise.
5.3.1.1 Active Pharmaceutical Ingredient [Non Sterile]: Assay, pH, Water content, Impurities etc.
5.3.1.2 Market complaints, investigations and planned corrective action.
5.3.2 Review of critical in-process controls and key API test results.
5.3.3 Review of all batches that failed to meet established specifications and related investigation.
5.3.4 A review of all deviations or nonconformances and related investigation.
5.3.5 Review of any changes carried out to the processes, system or analytical methods.
5.3.6 Review of results of the stability-monitoring program.
5.3.7 Product Recall, reason for Recalls and corrective actions taken / planned.
5.3.8 Returned Goods and Salvaged Goods.
5.4 Annual Product review shall be prepared by Quality Assurance as per the format given in Annexure I.
5.5 Annual Product Review shall be checked by Head – Production.
5.6 Manager – QA & RA shall approve Annual Product Review.
5.7 Annual product report should be prepared based on Annual product review and recommendation should be made in the report based on the review, if any change is desired.
5.8 The report should be sent to,
5.8.1 Head – Corporate Quality Assurance
5.8.2 Head – Production
5.9 All record shall be kept with Quality Assurance.
END OF DOCUMENT
Annual product review, quality assurance, product manufactured
