Tips & Tricks on Management Review & Product Quality Review – Part 1
In this blog series we’ll explore the Product Quality Review (PQR) and Management Review (MR), two essential parts of every pharmaceutical organization which operates under the GMP regulatory requirements. We’ll explain the purpose, the advantages and when you should perform a PQR or Management Review. This first post focuses on the Product Quality Review.
Product Quality Review (PQR)
The product quality review in the GMP’s are an opportunity for the organization to review the performance annually, but perhaps more important, it provides management an opportunity to understand what the figures mean and the significance of any changes. In short, the PQR in a GMP environment contains; the consolidation of the produced batches and the products introduced to the market, an overview of the complaints, recalls, etc. (any quality related issues) and other related subjects.
Besides the fact that PQR is a very useful exercise, the regulatory authorities require it. The EU GMP requires it as part of Chapter 1 – Pharmaceutical Quality System (EudraLex Volume 4 – Part 1), the U.S. FDA has the 21 CFR 211 (211.180 APR) and the WHO introduced the concept in WHO TRS 999, 2016.
Many organizations see the PQR as a mandatory exercise only. In the spirit of; we’ll do it because the GMP tells us we have to do it. This point of view is wrong. Trending of your performance serves a business case as well, how can you sell more products if you don’t know where to improve? The PQR should not be seen as a mere QA exercise but as vital KPI information for upper management.
When you should not perform a PQR;
- When it’s the only review you do,
- When management is not participating,
- When you only look at one year, rather than multiple years,
- When it’s not a part of the quality culture of the organization,
- When it’s not an integral part of the QMS,
- When it’s seen as a mandatory exercise.
When you should perform a PQR;
- When it’s a consolidation of all other reviews,
- Management is participating actively,
- When it’s a part of the quality culture of the organization,
- When it’s an integral part of the GMP QMS,
- When it results in thought-trough CAPA’s (investments) in future product quality, efficacy and increased outputs
The Product Quality Review (PQR) has been imbedded in the GMP since 1976. The U.S. FDA was the first regulatory organization to require the PQR’s to be implemented albeit under a different name; “Product Annual Review” (PAR) or “Annual Product Review” (APR). The EU GMP introduced the PQR in 2006, the WHO followed in 2011.
The objectives of the PQR are as follows;
Establish the consistency of the existing process,
- The appropriateness of current specifications
- Starting materials and finished product,
- Highlight any trends and to identify product and process improvements
The figures below detail the Product Quality Review from the perspective of different guidances;
PQR Contents (GMP)
The following contents could be part of your PQR, some regulatory authorities require less, this list is not all-encompassing and only serves as an example of the contents of a PQR.
- Review of starting materials including packaging
- Assessment of representative number of batches
- Review of IPC and FP
- Review of OOSs and related investigations
- Review of deviations, non-conformances and associated analyzes and achieve CAPA
- Review of changes in production processes and analytical methods
- Review of MA variations submitted, approved / rejected incl. Export
- Review of salvaged / repaired products
- Assessment of stability program results and associated trends
- Review of quality related returns, complaints and recalls and associated investigations
- Review of previous PQR regarding product, process and material CA
- Review of post-marketing obligations with regard to new MAs and variations
- Qualification status for relevant machines and utilities
- Review of contractual arrangements according to Chapter 7
- Impurity profile comparison with historical data and submission of regulations
- Responsible for accurate and timely reporting
- Responsibilities of contract manufacturer
- Written PQR procedures
- Written report
- Documentation regarding CA reasoning
- Timely and effective handling CA
- Ongoing Management Review of follow-up actions as part of self-inspections