Annex 15

EU Guidelines for GMP-Chapter 1 “Quality Management” revised to align with ICH Q10

As of the 31st of January 2013, Chapter 1 will come into operation titled as “Pharmaceutical Quality System” in order to align with the concepts and terminologies described in the ICH Q10.

The current version of Chapter 1 describes “Quality Management” and how it incorporates Good Manufacturing Practice (GMP). The new revision further clarifies that GMP applies to the lifecycle stages, from the manufacture and transfer of investigational products to the commercial stage and on to product discontinuation.

The Pharmaceutical Quality System can extend back to the product development stage in the lifecycle, although optional as per ICH Q10, it “should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities”.

The document also outlines that the Pharmaceutical Quality System design should incorporate risk management principles. It should be appropriate for the manufacture of medicinal products to ensure that product realisation is well planned and product/process knowledge is monitored, controlled and maintained throughout all lifecycle stages.

There is also an emphasis on the control of planned changes and the prospective assessment of their impact on product quality, as well as the management of deviations using quality risk management principles, identifying corrective actions and/or preventative actions (CAPA’s).

The responsibility of the Pharmaceutical Quality System is on senior management and that it is “adequately resourced and that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organisation”. A Quality Manual or equivalent document should describe the system, and periodic management review of the system with senior management, should “identify opportunities for continual improvement of products, processes and the system itself”.

The document is available here.

By Eoin Hanley
Senior Consultant-PharmOut

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