Changes to Chapter 5 of the EU GMP Guide Proposed

GMP News
20 June 2007

Changes to Chapter 5 of the EU GMP Guide Proposed

The EMEA Ad Hoc GMP Inspection Services Group has published a concept paper regarding proposed changes to Chapter 5 of the EU GMP Guide.

The obligation for manufacturing authorisation holders to use active substances as starting materials that have been manufactured in accordance with GMP introduced through Art. 46f (50f) of Directive 2001/83(2) is currently not clearly reflected in the detailed guidelines on GMP. The expectations for the qualification of active substances manufacturers and suppliers should be updated in the light of the new legislation and aligned to other existing guidances.

Although Chapter 5 does provide some guidance on the qualification of suppliers, it neither emphasises the obligation to ensure that active substances are produced in accordance with GMP nor is there any guidance as to how this could be achieved. Furthermore the chain of supply for some active substances can be complex and it is felt that guidance should take this into account.

The Group recommends a revision to Chapter 5 of the GMP Guide. It specifically considers sections 5.25 and 5.26 as the parts requiring amendment in connection with the obligation to ensure that active substances and certain excipients comply with GMP. It recommends that testing of starting materials be dealt with through a new section inserted after section 5.31 which would ensure that a harmonised approach will be achieved and accepted.

The proposal will update the existing chapter 5 of the GMP Guide and if possible will be phased in at the same time with contents of the Concept Paper entitled "Dealing with the need for updated GMP guidance concerning dedicated facilities in the manufacture of certain medicinal products", published in February 2005.

The revised guidance will apply to medicinal products already authorised and on the market, as is normal for amendments to the GMP Guide. Release for consultation should be expected by the end of September 2007 with a deadline for comments by the end of March 2008. The expected date for adoption of a final text by the European Commission is October 2008.

Learn more about inspections, audits and related topics in the following ECA course:

Testing active pharmaceutical ingredients and excipients is one of the main tasks of the quality control units in the pharmaceutical industry. You will learn more about these requirements in the following ECA Course:

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

Source: EMEA Inspection News:

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