ANNUAL PRODUCT REVIEW Patchara Kootiratrakarn Independent consultant.

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Presentation transcript:

ANNUAL PRODUCT REVIEW Patchara Kootiratrakarn Independent consultant

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

Responsibility QA manager Functional area managers Site Annual Product Review committee

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

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

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

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)

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

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)

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

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

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