Product Quality Review (PQR) Best Practices | EU GMP vs FDA | Avoid 483 & GMP Findings

Product Quality Review (PQR) Best Practices | EU GMP vs FDA | Avoid 483 & GMP Findings
Product Quality Review (PQR) is one of the most critical GMP requirements under EU GMP and US FDA regulations. Poorly prepared PQRs are a major reason for FDA 483 observations, EU GMP major deficiencies, and warning letters.

In this video, you will learn Product Quality Review best practices followed by top pharmaceutical companies and clearly understand the difference between EU GMP PQR and FDA Annual Product Review (APR).

✅ Topics Covered in This Video

✔ What is Product Quality Review (PQR)
✔ EU GMP Chapter 1 PQR requirements
✔ US FDA Annual Product Review – 21 CFR 211.180(e)
✔ Mandatory PQR elements and checklist
✔ Deviation, OOS, CAPA & change control trending
✔ Common PQR deficiencies cited in inspections
✔ How to avoid FDA 483 and EU GMP observations
✔ Who should prepare and review PQR in pharma

Video Chapter
00:01:55 What is Product Quality Review?
00:04:56 Why Product Quality Review is Critical?
00:08:08 EU GMP vs FDA – Key Differences
00:11:19 Mandatory PQR Elements
00:13:59 Best Practices for Effective Product Quality Review
00:17:07 Common PQR Deficiencies Observed by Regulators
00:20:04 Who Should Master Product Quality Review?
00:22:54 Your Action Plan for PQR Excellence

This video is highly useful for:
🎯 Pharma QA & QMS professionals
🎯 GMP trainees & freshers
🎯 Regulatory affairs professionals
🎯 Qualified Person (QP) aspirants
🎯 OPRA, NAPLEX, MOH, Prometric exam candidates

📌 Regulatory Focus:
EU GMP | US FDA | ICH Q10 | Pharmaceutical Quality System

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💬 Comment “PQR TEMPLATE” to get a ready-to-use Product Quality Review checklist & format.