Believe it or not – “Knowledge Management“ is a part of the Pharmaceutical Quality System. ICHQ10 lists it as an “Enabler“ system for process and quality assurance. And although ICH itself may not intend to make knowledge management a formal and mandatory quality sub-system, let´s be honest:

Once mentioned in a guideline of such prominence, it will(!) eventually become a perfectly normal compliance demand for local and international regulatory GMP inspections. And Q10 has been published for a long time! And although more geared to the developing drug product industry, this will likely become just as relevant for any GMP manfacturer.

My personal experience is however, that knowledge management is hardly ever part of regulatory compliance inspections. This may change though in the near future, since emphasis on process and product knowledge has been increasing in ICH and non-ICH guidance documents during the recent years. For example, younger approaches to process development and validation (EMA), focussed risk based approach in IMP and ATMP regulations, and of course the upcoming ICHQ12 document are excellent indicators that the term “Knowledge Management“ is here to stay.

But what is “Knowledge“? And how is it to be managed? And what is the endpoint of all this?

In a real GMP world (which is a bit more encompassing than any regulatory landscape to this day) Knowledge in a broader sense is not only data and empirically acquired conclusions and practical know how. It is a mix of typically documented and GMP-relevant data + the pool of the employees´ education and training + the sum of the employees´ skills a company has at its disposal. So much of all this may not ever be documented or captured, nor will it be kept or transferred, neither will it utilized in any way.

This is a great waste in quality management robustness and financial efficacy. Just think of all the strategic and quality relevant mistakes Your company may actually not(!) repeat had anyone remembered a certain problem solution or quality situation! Think of the gain a company or just a department can yield by keeping skill rather than just data. And consider the protection from knowledge loss through countless crossmoves of employees, and of entries and exits of staff!

So… How to comply with Knowledge Management Expectations? And how to get a hold of relevant and undocumented knowledge? How can a quality system ensure knowledge and skills transfer? How can such a valuable asset be reasonably secured?

One part of the answer is:

Every GMP site already has systems for managing important and critical knowledge in place – but is essentially unaware of them in this formal knowledge management respect.

CAPA, Change Management and Product Quality Review are only examples (did I really forget to mention… „Training“?). The entire ICH “Quality By Design“ workflow contains knowledge management nuggets and blueprints. Structuring this knowledge properly is a big chunk of all of this.

Another answer is:

Undocumented knowledge must be captured with a targeted approach.

The Key to Both is to be intentional about “Knowledge Management“ in the Quality System. If You can convince the right people that this is actually important, the rest will fall into place. And yes, implementation will take time, but it does pay off.

So… what do You think? You don´t believe in it? That´s alright… especially for Your competitors.

Es informiert Sie:
Dr. rer.nat Dietmar Gross
Consultant von gmp-experts

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