1. ANNUAL PRODUCT REVIEW
Patchara Kootiratrakarn
Independent consultant

2. Definition Annual Product Review
A compilation of identified critical data related to licensed products and intermediates manufactured at a local site

3. Responsibility QA manager Functional area managers
Site Annual Product Review committee

4. QA manager To ensure that, responsible for:
A system to compile APR’s exists, and is managed and maintained
APRs are compiled on an annual basis, in compliance with the requirements of SOP
Final approval of each APR report
Evaluate data/ information comprising the APR, to assess trends, identify adverse trends, and determine the need for changes in specifications or manufacturing and or control process

5. QA Manager
Co ordinate actions arising from information found in the APR reviewing process, and follow up on the proposed CAPA to implementation
>>Responsibility

6. Functional area manager
Providing data on time
Analysis of data on time
Recommendation for improvement as indicated by the SOP
Implementation on CAPA proposal related to the department
>>Responsibility

7. Site APR committee Site APR committee comprised of
APR Report Author & Authorizer
Managing Director
QA and QC Managers
Production Manager
R&D Manager
Planning and Supply Chain Manager
Other concerned departments (Marketing manager, engineering manager etc)

8. Site APR committee Responsible for
Review, evaluate APR and decide on CAPA and/or recommendations
Approval of each APR final report
Support and executing the agreed action plan based upon the APR

9. How to proceeds? Gather and evaluate raw data (department manager)
Edit and APR report writing
(QA department)
Review and comment to the draft report
(APR committee)
Comment, conclude with CAPA proposal (APR committee)
Present to APR committee
(QA and related department)
Final APR report approval
(APR committee)
CAPA implementation
(department manager)
Summarize in the next APR
(QA department)

10. Outline of the APR report (1 of 3)
Executive summary
Introduction and product overview
Manufacturing/ process data
Review of raw materials and packaging materials
Significant and related deviation
Analysis of rejection
Product testing and trend analysis
Stability study and trend analysis

11. Outline of the APR report (2 of 3)
Review of reference samples and retention samples
Review of related changes
Validation activities
Technical & quality agreements
Customer technical complaint/ Medical complaint
Product return
Product recall

12. Outline of the APR report (3 of 3)
Complaint to supplier
Regulatory activities
Pharmacovigilance information
Review of Corrective and Preventive actions
Environment monitoring results
Observation from external inspection
Conclusion and recommendation