Product quality review Flashcards
What is your understanding of PQR? Can you describe what is covered in PQR in terms of
products manufactured at your site?
Summary of the product performance – typically done annual depending on number of batches manufactured.
Includes :- Supply Chain, Changes, Deviations, CAPA’s, Post Marketing Commitments, Complaints, Recalls, In Process Checks, CPV data.
How are statistics used in the review of PQRs?
Control charts for stability and CPV. Comparison for manufacture and analytical data following tech transfer of manufacture or testing
What is the purpose of a Product Quality Review and what should it cover?
Purpose – Verify existing process consistency and current specs appropriate & ID product & process improvements. Normally Annually. QP & MAH ensure timely & accurate.
Starting & Packing Materials
IPC & FP Test results
OOS & Rejected Batches
Deviations, Investigations & CAPA
Changes – Process & Analytical Methods
MA & variations & post marketing commitments
Stability & Adverse Trends
Returns, Complaints & Recalls
Previous CAPA for process & equipment
Qualification & validation of facilities & process
Tech Agreements
Product Quality Reviews, should these be performed for IMP?
Chapter 1 states Regular periodic or rolling quality reviews of all authorised medicinal products, including export only products. PQRs are not applicable to IMPs as they are not marketed product
