Regulatory Inspectors and PQR: Questions They Commonly Ask

Facing a regulatory audit? Your Product Quality Review (PQR) might just be the most scrutinized document in the room. Whether it’s the FDA, MHRA, or WHO, inspectors expect more than a checklist — they expect a narrative that shows you understand your processes and are improving them continuously. 

Here are the common questions regulatory inspectors ask when reviewing your PQR: 

1. Was the PQR completed within the required timeframe?

 Timeliness is a basic compliance requirement. Many regulators, including the FDA, expect annual PQRs to be completed within 30 days of the review period’s close. Delays can signal system inefficiencies or lack of ownership. 

2. What changes were made based on last year’s PQR?

 Inspectors are keen to see that PQR isn’t a passive document. If no CAPAs, risk re-assessments, or process improvements followed the review, they’ll question whether it was truly evaluated. 

3. Are vendor or material trends part of this PQR?

 A comprehensive PQR must reflect the entire product lifecycle — that includes input materials. If an API vendor caused batch deviations or failures, this must be documented. 

4. Has this PQR been used to support regulatory filings or variations?

 Your PQR can and should feed into regulatory strategies. If it highlights process robustness or batch consistency, that information can strengthen a variation or filing update. 

5. Were all marketed batches included in the review?

 Exclusions or gaps (e.g., tech transfer batches, clinical lots) must be justified. A PQR that omits critical data points can be seen as incomplete or non-compliant. 

Final Thoughts 

 Think of your PQR as your product’s story for the year. It tells regulators not only what happened, but what you learned — and what you’re doing better. Treat it as a tool, not a tick-box, and you’ll pass that audit with confidence.