On 10 October 2005, the Enterprise and Industry Directorate-General of the
EC Commission published the restructured EU-GMP Guideline. This
restructuring is a consequence of the requirements from the Directives
2004/27/EC and 2004/28/EC referring to medicinal products for human and
veterinary use (see our detailed GMP
News No. 572 of 4 July 2005). These guidelines require that only those
APIs be used as starting materials that have been manufactured in
compliance with the detailed GMP guidelines for starting materials.
Besides, the document lays down that the basic principles of a Good
Manufacturing Practice for APIs will be passed in the form of
comprehensive guidelines.
According to these requirements, the EU-GMP Guide was divided into two
parts:
- Part I: Basic Requirements for Medicinal Products
- Part II: Basic Requirements for Active Substances Used as Starting
Materials
As in the past, Part I contains the chapters 1 to 9 ("Quality
Management" to "Self Inspection").
The contents of Part II are identical with those
of the former Annex 18 ("Good manufacturing practice for active
pharmaceutical ingredients"); only the introduction has been changed.
However, the scope has been extended: it refers to APIs for the
manufacture of drug products for human use and for veterinary use.
Within the framework of this revision, Annex 1
through 17 will also be revised, i.e. regulatory gaps will be bridged,
and overlaps with each other, removed. However, up till now, no revised
texts have been published. A corresponding "concept paper" by the EC's
Ad hoc GMP Inspection Service Group, which was published for commenting
in May this year, contains suggestions for changes in Annexes 2
(biologic products), 3 (radioactive drugs), 6 (medical gases) and 7
(herbal medicinal products). The deadline for comments was at the end of
August so that we will not see any revised annexes too soon.
At the same time as the revised GMP Guide, the EC
Commission published the accordingly changed "Introduction to the GMP
Guide". In parallel with the restructuring
of the EC GMP Guide with the stress on the GMP Guide for active
pharmaceutical ingredients, the German legislative body published a
draft for the pharmaceutical and API ordinance. Other European
countries, too, will transpose the directive to use solely GMP-compliant
APIs as starting materials into national legislation. The deadline for
this procedure is 30 October 2005.
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