In the course of the worldwide harmonisation of GMP rules, the European Commission also integrates the principles of the ICH Guideline Q10 "Pharmaceutical Quality System" into the EU GMP Guide. This affects Chapter 1 "Quality Assurance System" and Chapter 2 "Personnel".
This news item describes the changes and amendments to Chapter 2 "Personnel". In general, the term "quality assurance" is replaced by "quality management" or "quality management system". Changes of this kind are not mentioned separately in the following.
The Chapter 2 "Personnel", which hitherto consisted of 5 subchapter, has been extended by 2 new subchapters "Consultants" and "Management of Change in Product Ownership". In the following, the most important changes and amendments of the individual subchapters are listed:
No changes were made to this part.
Two fundamental amendments have been made. As a new feature, section 2.1. formulates expressly the requirements to the management to provide sufficient resources for the implementation and maintenance of the quality management system and to continually improve its effectiveness. The 2nd addition was the introduction of section 2.3. Primarily, the senior management of a company is addressed reminding it of its responsibility for quality and efficiency of the quality management system. !!!Attention; it has been forgotten to adapt the following section numbers!!!
In the essence, this chapter has remained the same. At the beginning, it is again emphasised that the senior management is responsible for appointing the Key Management Personnel.
Essentially, this chapter has remained unchanged. Apart from the theoretical and practical basic training in Good Manufacturing Practice, now an introduction to the quality management system of a company is also required.
This subchapter is new and corresponds in the essence to the US-American requirements from CFR Part 211.34.
Management of Change in Product Ownership
This subchapter has newly been included and is identical with Chapter 2.8 of ICH Q10. It is meant to ensure that, in case product ownership changes (e. g. company buy-outs / company sales), a continuous chain of responsibility is kept up by the concerned firms, and it should be guaranteed that the information necessary for this is transferred to the new owner.
The draft for the revision can be found here.
The link to the corresponding page of the European Commission can be found here.
Dr Andreas Mangel
On behalf of the European Compliance Academy (ECA)