Quality Product Review / Annual Product Review

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Quality Product Review / Annual Product Review

This Standard Operating Procedure (SOP) describes the program necessary when conducting the Annual Product Review (APR) which must be performed for each commercial product. The purpose of this SOP is to provide clear guidance on how to perform an APR with the purpose to verify the consistency of the process, to assess trends, to determine the need for changes in specifications, production, manufacturing, and/or control procedures and to evaluate the need for revalidation.


Quality Product Review SOP 

This SOP applies to all products commercial manufactured on site. It includes all commercial Active Pharmaceutical Ingredients (API), Drug Product and Medical Devices manufactured on site and for third parties used as contract manufacturer.
Where semi-finished product is processed in multiple Sites, all Sites must participate in the Annual Product Review process by supplying information to the facility of release.


Regulatory basis, reference documents

  • FDA Code of Federal Regulations 21, Part 211 Subpart I (Laboratory Controls) and J (Records and Reports)
  • FDA Human Drug CGMP Notes 1998
  • PIC Document PH 2/87, Guideline for the Production of Pharmaceutical Drug Substances
  • PIC Document PH 5/92, Guideline to Good Manufacturing Practice for Pharmaceutical Products


Table of Content (just Headers):

1          Purpose

2          Objective

3          Regulatory basis, reference documents

4          Responsibility and accountability

4.1       Company Management

4.2       Quality Management Representative/ Quality Assurance

4.3       Manufacturing

4.4       Quality Control Department (QC)

4.5       Regularly Affairs and Clinical Safety

5          Related documents

6          Definitions

7          Procedure

7.1       General

7.2       Statistic

7.2.1    Trending

7.2.2    Mean Charts

7.2.3    Range Evaluation

7.3       APR Report

7.3.1    Conclusion

7.3.2    Last years Recommendations           

7.3.3    Manufactured Batches

7.3.4    Batches rejected

7.3.5    Batches reworked/reprocessed

7.3.6    Deviations, Out of Specification Results (OOS)

7.3.7    Environmental monitoring data

7.3.8    Product Specification/Method Changes

7.3.9    Retain samples (US)

7.3.10  Changes effected (Change Control)

7.3.11  Analytical data

7.3.12  Release Data

7.3.13  Stability data

7.3.14  Validation review

7.3.15  Recalls           

7.3.16  Customer Complaints and Returns

7.3.17  Adverse Drug events

7.3.18  Inspections from any official inspectorate

7.3.19  New recommendations

8          Attachments

8.1       Attachment 1: Annual Product Review (APR) Report for Product (7 pages)

9          SOP distribution

10        Health, safety and environmental considerations


Size and Format

    Microsoft Office 2003

    Word File

    19 pages procedure

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