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The US-American supervisory authority is often asked whether there is a
list of equipment for pharmaceutical manufacture approved by the Agency.
The clear answer is: no. At http://www.fda.gov/cder/guidance/cGMPs/equipment.htm you will find
current questions on equipment with the corresponding answers and
explanations by FDA.
Within its cGMP Initiative of August 2002, apart from the field of
equipment, the FDA established a questions-and-answers forum on further
topics:
- Organisation and Personnel
- Buildings and Facilities
- Control of Components and Drug Product Containers and Closures
- Production and Process Controls (updated 5/18/2005)
- Packaging and Labeling Control
- Holding and Distribution
- Laboratory Controls
- Records and Reports
- Returned and Salvaged Drug Products
At http://www.fda.gov/cder/guidance/cGMPs/
you can find all further information.
Compiled by:
Dr Andreas Mangel
On behalf of ECA
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