official publication of the draft GMP for active pharmaceutical
ingredients from working group ICH Q7A has been long awaited.
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
what does this all mean?
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.
this Guide still has draft status, it is expected that only minor changes
will be made until the final document is published.
publication signifies the codification of the state of the art in the case
of GMP for active pharmaceutical ingredients.
document answers the following questions:
does API manufacturing begin?
are the requirements as regards rooms and equipment?
documents are necessary for production, storage and quality control?
requirements are to be placed on validation and change control?
is to be observed during reworking and reprocessing?
16, 17, 18 and 19 concern the special regulations, which include:
manufacture of APIs
as regards agents, brokers, distributors, repackers and relabelers
guidance for APIs manufactured by cell culture / fermentation
for use in clinical trials
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.
here to read the program.
here to load the ICH Guide!