What are the contents of Annual product quality review (APQR)?

Contents of an APQR is:

1.       Introduction

2.       Number of Intermediates and APIs batches produced

3.       Review of output for all Isolated Intermediates and Finished Products

4.       Review of Critical Quality attributes of In-process, Isolated Intermediates and Finished Products

5.       Summary of changes made during the year with respect to equipment, Process, Specifications, and Methods, Raw materials and others.

6.       List of Deviations and a brief description of deviations and action taken.

7.        List of customer complaints; Return goods and Recalled goods along with description and actions are taken.

8.       Number of Reprocessed and Reworks batches in all stages during the year-2009

9.        Review of Key starting materials and Primary packing materials and Rejections.

10.   Review of Bioburden on the product (for a minimum of 3 batches)

11.   Review on Stability studies and Summary

12.    List of Out of specifications for Finished products

13.   Review of Retained samples quality (Finished product)

14.   Review of Validation packages (Process, Equipment, Procedure)

15.   Status of Drug Master File (if any), Drug Master File new updates

16.    Details of special training provided to employees in case of Deviations or Complaints received regarding a particular product

17.   Summary Report