Is Knowledge Management a Part of the Pharmaceutical Quality System?

To make it short: yes, it is. Although Knowledge Management (KM) is not a formal GMP requirement or a mandatory quality system to be implemented, ICH Q10 lists KM as an "enabler" for an effective pharmaceutical quality system, like the it does with Quality Risk Management, QRM. With ICH Q10 defining KM and QRM as two key enablers, it presents a comprehensive quality system model for the lifecycle of a product: "Use of knowledge management and quality risk management will enable a company to implement ICH Q10 effectively and successfully. (...) Product and process knowledge should be managed from development through the commercial life of the product up to and including product discontinuation."
The EU GMP guidelines come from a different direction and see the PQS as a prerequisite: (1.4) "A Pharmaceutical Quality System appropriate for the manufacture of medicinal products should ensure that: (...) (ii) Product and process knowledge is managed throughout all lifecycle stages".

According ICH Q10, KM is a "systematic approach to acquiring, analysing, storing, and disseminating information related to products, manufacturing processes and components."

Diagram of the ICH Q10 pharmaceutical quality system model

Regulatory Requirement?

Do regulatory agencies expect to see a formal knowledge management approach during inspections? The answer is given in the ICH Q9(R1) Annex 1: Q8, Q9 and Q10 Questions & Answers (R5): "No. There is no regulatory requirement for a formal knowledge management system. However, it is expected that knowledge from different processes and systems is appropriately utilised."

As said above, ICH Q10 doesn't define Knowledge Management as being a bureaucratic requirement, but as important part of the PQS which can (together with QRM), support ICH Q10 key objectives:

• Achieving product realization,
• Establishing and maintaining a state of control,
• Enabling continual improvement.

As a consequence, KM should not be seen as a one-time task but an iterative journey. As knowledge evolves through activities like innovation, pharmaceutical development, process validation, and manufacturing, it must be continuously refined and shared.

One of the biggest challenges in KM is that it is more than just documenting information and data, but efficiently sharing expertise and insights residing in people and informal networks. Efficient KM systems must foster a structured knowledge flow with defined processes, roles and responsibilities. In this context, people need to be encouraged to share knowledge and embed KM into daily operations with processes tailored to the needs.

In an article in the GMP Journal, Dr Lars Lueersen states that "Knowledge management can be applied in order to use knowledge in an optimal way, to further develop it and to implement it in new products, processes and business areas. Already existing quality management systems as they are used in the pharmaceutical industry are understood as precursor to knowledge management and may serve as a good starting point" and that "knowledge multiplies by use".

Whether you are just starting your KM journey or looking to enhance existing practices, ECA's event on 17/18 September in Hamburg offers valuable insights for professionals at all levels.