EMEA Plans on Revising EC GMP Guide to Implement ICH Q10

Recommendation

10 December 2019
Copenhagen, Denmark

Full-day pre-course session Audit Trail Review

On 11 March 2009 the European Medicines Agency (EMEA) issued a so-called concept paper. In this paper the authority explains the problems in implementing the ICH Guideline Q10 "Pharmaceutical Quality System" in European legislation und thus proposes a revision of the EC GMP Guide. Following the approval of the ICH Guideline Q10 this transfer is mandatory for the EC.

The EMEA states that requirements regarding a pharmaceutical quality system are already implemented in the EC GMP Guide, and especially in chapter 1. For that reason the authority sees a potential risk for confusion in the regulatory requirements caused by a different terminology in the two documents. In addition to that, in EMEA's view the requirements defined in chapters 1 and 2 of the EC GMP Guide are not up to date any more. A revision is also necessary for the glossary as well as for the chapter 7 "Contract Manufacture and Analysis", as "Outsourcing" was emphasised in the final ICH Q10 version. Further issues to be addressed include:

• "Clearer guidance on the handling and investigations of deviations, Corrective and Preventive action and change control.
• Emphasising the role of senior management in ensuring that there is an effective Quality Management System to support GMP."

The first draft of the requirements is supposed to be published in July 2009 and is intended for finalisation within a year.

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

Source: EMEA CONCEPT PAPER ON THE IMPLEMENTATION OF ICH Q10