On 16 April 2008, the European Commission published a draft for the extension of
Part II of the EC GMP Guide for active pharmaceutical ingredients. With this
measure, the European Commission now intends to integrate Quality Risk
Management also into the GMP Guide for APIs in compliance with the recommendations of ICH Q9 and on the analogy of the
extension of Part I of the EC GMP
Guide for finished medicinal products. Meanwhile, ICH Q9 has been published
by the European Commission as Draft Annex 20 to the EC GMP Guide. Since the
Guide was re-structured, the annexes refer both to Part I and to Part II.
Therefore, an extension of the GMP Guide for APIs is a logical step. However,
the result of this step will be that Part II of the EC GMP Guide is no longer
identical to ICH Q7. This document had been the starting point for the
harmonisation of the GMP requirements on APIs in Europe, Japan and the USA.
The new section on Quality Risk Management has been introduced
as 2.2, making it necessary to re-number the following sections. The text
proposed by the European Commission is oriented towards the contents that were
suggested for the GMP requirements on finished medicinal products. The only wording that is different to what has been defined in Part 1 of the EU GMP Guide is that of 2.20. The following excerpt has been taken from the draft for
the Guide on APIs:
2.2 Quality Risk Management
2.20 To achieve the quality objective reliably there must be a comprehensively
designed and correctly implemented quality system incorporating Good
Manufacturing Practice, Quality Control and Quality Risk Management.
2.21 Quality risk management is a systematic process for the assessment,
control, communication and review of risks to the quality of the active
substance. It can be applied both proactively and retrospectively.
2.22 The quality risk management system should ensure that:
- the evaluation of the risk to quality is based on scientific knowledge,
experience with the process and ultimately links to the protection of the
- the level of effort, formality and documentation of the quality risk
management process is commensurate with the level of risk
Examples of the processes and applications of quality risk management can be
found, inter alia, in Annex 20.
The planned extension - now also for the field of APIs - shows that Quality Risk
Management has become an integral part of the regulations. Comments on this
draft can be sent to
GMP@emea.europa.eu until 31 October
On behalf of the European Compliance Academy (ECA)
Commission: Draft Part II - Basic Requirements for Active Substances used as