Is There a List of Equipment for Pharmaceutical Manufacture Approved by FDA?

GMP News No. 757

GMP News
4 July 2006
 

Is There a List of Equipment for Pharmaceutical Manufacture
Approved by FDA?

 
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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