Revision of EU GMP Guide Chapter 1 Published

The European Commission has published a proposal for the revision of Chapter 1 Quality Management Systems of the EU GMP Guide. The new draft includes comprehensive changes. Although the document bears the date November 2009, the publication did not take place before 4 January 2010 via a link on the EMEA page.

The revision had become necessary since the European Commission has to put the contents of ICH Q10 into European legislation. The resulting changes are very comprehensive. This already becomes clear from the title, which was changed from Chapter 1 on "Quality Management" to "Quality Management System" in order to emphasise that the GMP requirements now call for the detailed proof of a system for establishing, maintaining and further developing a quality management system. Furthermore, the following new sections were included into Chapter 1:

- Quality Management System
- Process Performance and Product Quality Monitoring System and Product Quality Review
- Management of Outsourced Activities and Purchased Materials
- Management of Review on the Quality Management System
- Monitoring of Internal and External Factors Impacting the Quality Management System
- Outcomes of Management Review and Monitoring

Moreover, several passages in Chapter 1 were expressed in more concrete terms. In this process, the principles of ICH Q10 were incorporated into Chapter 1. Even requirements like "continuous improvement", which will pose major challenges in the GMP-regulated environment due to the post-approval change/variation regulations, were adopted. Furthermore, the emphasis of the senior management's responsibility has been pointed out. The top management's responsibility known from ISO 9001 is now part of the GMP requirements, just like further ISO 9001 elements. Nevertheless, certification according to ISO 9001 will continue not to be relevant for pharmaceutical enterprises.

Other concrete requirements are those on the documentation of the QM System. For the first time, there is the call for a quality management manual (section 1.5). In it, among other things the management's responsibility for the QM system should be described in concrete terms. There is also a detailed description of the requirement to establish a CAPA procedure. Up till now, a CAPA system had not been defined expressly in this form. Now points 7, 8 and 9 of section 1.8 include a comprehensive description among others in connection with the requirement of quality risk management in compliance with ICH Q9 (identical with Annex 20 to the EU GMP Guide). According to this, scope of measures, formality and documentation of the necessary CAPA measures should be specified as the result of a risk assessment. Likewise, in section 1.12, the requirements of process performance, product quality monitoring system and PQR were linked to risk management as defined in ICH Q9. According to this, process performance and process capability are meant to be monitored continuously. The appertaining control measures should be based on a risk assessment. This section also includes a note on the use of data management and statistical systems. For the first time, there is also a statement on design space in the EU GMP Guide.

What will also be of major importance is the section "outsourced activities and purchased materials". Throughout the industry, more and more pharmaceutical processes have been outsourced. These activities will now have to be described in detail and become part of the QM system. In this context, the purchase of raw materials (active ingredients and excipients) also gets a special mention. The responsibility of the pharmaceutical company is stressed. This can also be of great legal importance, e. g. when damage is caused by a non-GMP-compliant or counterfeit raw material. Here, not only the purchase must become an integral part of the QM system; but apart from this, the responsibility is clearly allocated, too, through the above-mentioned integration of the senior management. Further management processes, like a regular review of the QM system and the assessment of internal and external changes (e. g. the assessment of the impact of a takeover/merger) are now included in Chapter 1.

For ECA members, we have created a document comparison contrasting the requirements of the current version of Chapter 1 with the new draft. In this document, you can see exactly where changes and deletions have been made. The document comparison can be found in the ECA Members Area.

Here you can find the new Draft on Chapter 1 of the EU GMP Guide.

Recommended event: The ECA is organising the "ICH Q9 and ICH Q10 Training Course" in Budapest from 21-23 April 2010.

Oliver Schmidt
On behalf of the European Compliance Academy (ECA)

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