Product quality review Flashcards

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1
Q

What is your understanding of PQR? Can you describe what is covered in PQR in terms of
products manufactured at your site?

A

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.

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2
Q

How are statistics used in the review of PQRs?

A

Control charts for stability and CPV. Comparison for manufacture and analytical data following tech transfer of manufacture or testing

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3
Q

What is the purpose of a Product Quality Review and what should it cover?

A

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

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4
Q

Product Quality Reviews, should these be performed for IMP?

A

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

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