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Periodic reviews - what to use them for?

PQR, QMR, CPV, VMP/VMR, Computerized systems' periodic reviews, who knows what else...we manufacture these summaries, but exactly what for? Sometimes we spend so much time compiling these documents that we forget what the purpose would be.


Of course, our first answer is: we compile these summaries because they are mandatory, and they are almost always checked by the inspectors/auditors. So they have to be fancy, detailed, etc.


But what should be the real purpose, the mission of these documents?


As I see, the purpose is simple (at least theoretically): among the usual workdays, rushing to release the batches, closing investigations, concluding validations, the need to write these documents should make us take a step back, and evaluate the overall health of our production (PQR) or overall pharmaceutical quality system (QMR), etc. These could be an essential part of implementing the continual improvement.


However, I can bet you just rush to make these reports, too. With a huge set of complicated queries from applications, graphs, copying and pasting the magical sentences from the last summary. There is no time for one thing: the real actual evaluation. How can we circumvent this situation?


Let me share three things to consider:


  • try to make all sections as simple as possible: the more data you show, the less chance you have to observe some valuable trends. Restrict yourself to the written laws to evaluate (EU GMP Volume 4 Chapter 1 Section 1.10 for drug products, ICH Q7 Section 2.5 for APIs).

  • if you have the means, automate and standardize all your queries and reports: apart from being quick, if the outlook of the evaluation is the same, you can more easily focus on the data and their meaning.

  • and when you are doing your everyday work, writing and approving deviations, change controls, complaints, etc., always take a moment to check data quality (e.g., classification of deviation, type of change, marked article IDs), since this is going to be the key to be able to do perfect automatic queries - otherwise you have to take the time the double-check all data before using them for evaluation, and I believe that's one of the most mind-crushing activities to do.


Using these approaches, you will have a much better chance to really deal with your product's (or process') health, you may be able to define some proper CAPAs to improve your process, and let me risk the possibility of you having some fun doing that :)

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