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