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The
official publication of the draft GMP for active pharmaceutical
ingredients from working group ICH Q7A has been long awaited.
Now
it's here, the “Draft Consensus Guideline – Good Manufacturing
Practice Guide for Active Pharmaceutical Ingredients (APIs)”. This draft
was published for consultations on July 19, 2000 as Step 2 of the ICH
process.
Now
what does this all mean?
First
of all this means that the European Union, Japan and the USA (FDA) have
agreed on a common Draft Guide. What is more, owing to the World Health
Organization's observer status, the Pharmaceutical Inspection Convention
Scheme (PIC/S) and, inter alia,
China, India and Australia, a worldwide harmonization has been achieved.
Although
this Guide still has draft status, it is expected that only minor changes
will be made until the final document is published.
The
publication signifies the codification of the state of the art in the case
of GMP for active pharmaceutical ingredients.
The
document answers the following questions:
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When
does API manufacturing begin?
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What
are the requirements as regards rooms and equipment?
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What
documents are necessary for production, storage and quality control?
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What
requirements are to be placed on validation and change control?
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What
is to be observed during reworking and reprocessing?
Chapters
16, 17, 18 and 19 concern the special regulations, which include:
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Contract
manufacture of APIs
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Requirements
as regards agents, brokers, distributors, repackers and relabelers
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Specific
guidance for APIs manufactured by cell culture / fermentation
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APIs
for use in clinical trials
This
year the European GMP Conference for Active Pharmaceutical Ingredients is
taking place for the third time. The conference, which was held in
Brussels in the two previous years, is organized by APIC, a sector
committee of the European Chemical Industry Council (CEFIC). The
conference will take place in Hamburg on September 6 -8, 2000.
Click
here to read the program.
Click
here to load the ICH Guide!
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