Q339 · What is an “Annual Product Quality Review”…

Q339 · Category G: Quality management and compliance systems (Q301–Q350)

The annual Product Quality Review (PQR) is a core GMP requirement that applies mainly to medicine manufacturers. Manufacturers must review each medicine annually, compiling and analysing all data from the previous year on production controls, test results, deviations, changes, complaints and recalls, among other matters. This enables them to assess process consistency and the suitability of current specifications, and to identify trends for improvement. Medicine wholesalers are not required to conduct a PQR as detailed as that performed by a manufacturer. However, adopting the concept of an ‘annual review’ and conducting a comprehensive, data-based annual ‘health check’ of their own quality system is a highly valuable best practice.

📘 Regulatory basis

PQR is an express requirement for manufacturers under Chapter 1 of the PIC/S GMP Guide. For wholesalers, GDP places greater emphasis on “management review”, which has a similar purpose to PQR in systematically reviewing and improving the quality system. However, PQR focuses more on specific “products”, while management review focuses more on the overall “system”.

📗 Drew Tang's recommendations

We recommend that wholesale clients incorporate the principles of PQR into their management review preparations. For example, before a management review, prepare an annual quality report containing trend analyses of key quality indicators from the past year, such as the types and frequency of customer complaints, categorised statistics on deviation root causes, changes in supplier performance, and recall or return trends. This data-based review can add depth to management reviews and make the resulting decisions more targeted.

📕 Risk notice

Although a wholesaler’s failure to conduct a PQR will not directly constitute a breach, if your quality system has no annual, systematic review mechanism of any kind, whether a PQR or an in-depth management review, your QMS may be in a state of “keeping your head down and working without looking up”. This may lead to systemic problems being overlooked for a long time until they develop into serious compliance incidents.

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang

Business Manager Tang Shangyong (Drew Tang) will review your products, operating model, licence type and preparation requirements with you one-to-one. The precise service scope is confirmed in writing; pharmaceutical duties are carried out by legally qualified personnel, and approvals are determined by the competent authorities.

What is an “Annual Product Quality Review” (PQR)? Do wholesalers need to conduct one?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang