New EU GMP Chapter 1 published with comprehensive Changes.

The Directorate-General for Health and Consumers (DG SANCO) of the European Commission has published the final version of the revised Chapter 1 of the EU-GMP Guide, which will now be called “Pharmaceutical Quality System”. Chapter 1 was amended in order to align with the concepts and terminology described in the ICH Q10 tripartite guideline on Pharmaceutical Quality System and includes comprehensive changes. The deadline for coming into operation is 31 January 2013!

Some of the changes are very comprehensive. This already becomes clear from the title, which was changed from “Quality Management” to “Pharma Quality System”. This new term can be found constantly in the document.

Chapter 1 emphasises that GMP “applies to the lifecycle stages from the manufacture of investigational medicinal products [IMPs], technology transfer, commercial manufacturing through to product discontinuation” but that Quality Management “covers all matters, which individually or collectively influence the quality of a product”. Therefore, “Quality Management incorporates Good Manufacturing Practice.” When it comes to pharmaceutical development, the extension of the Pharmaceutical Quality System remains optional. But if implemented it should “facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities”.

Although ICH Q10 is still reproduced in Part III of the EU-GMP Guide, several principles of ICH Q10 were incorporated into Chapter 1. Even requirements like continuous and continual improvement for products and processes were adopted.

Furthermore, the emphasis of the senior management’s responsibility has been pointed out: “Senior management has the ultimate responsibility to ensure an effective Pharmaceutical Quality System is in place. (…) This leadership should ensure the support and commitment of staff at all levels and sites within the organisation to the Pharmaceutical Quality System”. That means that top management’s responsibility known from ISO 9001 is now part of the GMP requirements, just like other ISO 9001 elements.

Up till now, a CAPA system had not been defined expressly in this form. Now points 1.4 (XV) and 1.8 (VII) clearly require appropriate corrective actions and/or preventative actions (CAPAs) and root cause analysis in connection with Quality Risk Management principles.

Besides the Product Quality Review (PQR, now described in part 1.10), a Management Review becomes necessary to “identify opportunities for continual improvement of products, processes and the system itself”. This review should involve senior management as well. The PQR itself now should also incorporate a review of supply chain traceability of active substances.

Other concrete requirements are those on the documentation of the QM System. For the first time, there is a requirement for a Quality Manual (section 1.7), describing the quality management system and the associated responsibilities.