The GMP Management Review

The GMP Management Review: A highly underestimated instrument of quality assurance

The GMP Management Review: A highly underestimated instrument of quality assurance

The management review is not a new instrument in the GMP quality system; it is also a topic within the latest EU GDP Guidance. Nevertheless: in reality, many GMP companies still do not really know how to deal with this topic – the implementation of the management review is completely lacking in some places. Where does that come from…?

Quality system ICHQ10

It is often not clear to the management and senior management of a GMP company how this requirement for a management review fits into the existing quality system, let alone what the background and purpose of the requirement is. The answer is described in the Guidance on the Pharmaceutical Quality System ICHQ10 – as part of the EU GMP Guidance (Part III Q10), every company should be familiar with this document for its own benefit.

The lack of establishment of the management review

However, the lack of establishment of the management review is not just another item on the list of inspection deficiencies – unfortunately, it is much more serious: for many companies, the management review is part of an actual reorganization of the quality system – in accordance with ICHQ10.

GMP guidelines

Gone are the days when anyone could set up a quality system as they saw fit based on the chapters of the GMP guidelines – a collection of SOPs and processes from the guidelines that were linked together as best they could to form a quality system. Anyone who has not yet realized that ICHQ10 must be the leading principle – the big bracket around the pharmaceutical quality system of a GMP company – has some catching up to do.

ICHQ10

Does this mean having to completely rebuild a quality system? In most cases, adaptation to ICHQ10 should be feasible with manageable effort. However, anyone who has not taken ‘quality management’ in the GMP guidelines seriously for many years – i.e. has seen it more as a formality than an effective management tool – will now have to invest in order not to completely miss the boat when it comes to the GMP compliance required today. And that’s right: this applies not only to the developers of new drugs and their legacy products, but also to manufacturers of generics.

Conclusion

The ray of hope: The management review according to ICHQ10 is not just a manageable hurdle. In particular, the mandatory involvement of senior management means that this is the best opportunity to date to overcome the long-standing and well-known shortcomings of the in-house quality system.

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Dr. rer. nat. Dietmar Gross

Vita

• COO Experts Institut
• Senior Project Consultant
• Apotheker
• Langjährige internationale Projekttätigkeit in Europa, Nordamerika, Asien, Russland
• Sachkundige Person (D – AMG, AMWHV, CH – HMG, AMBV)
• Breite Compliance Expertise im Commercial (c)GMP- und Development GMP-Bereich (IMP-GMP)
• Langjähriger Third-Party GMP-Auditor (GMP- und Non-GMP)
• GMP/GDP-Trainer seit 2010
• Quality Culture Mediator
• Trained in cross-cultural aspects of communication, contextualization, and cultural anthropology as part of an MA.MIn and DIcs enrollment at Grace College&TS, US.