FDA Guidelines for Inspection
FDA Guidelines for Inspection
(OP)
Can anyone give me the EXACT requirements for FDA validation of construction projects. I am particularly interested in the requirements welding documentation, visual examination etc. I know ASME BPE is a standard, but it is not the law from what I gather. Any clues ?!?
The APIGUY....





RE: FDA Guidelines for Inspection
Regards,
RE: FDA Guidelines for Inspection
The APIGUY....
RE: FDA Guidelines for Inspection
RE: FDA Guidelines for Inspection
In general a good reference document is the ISPE Baseline Vol 1. Guideline for new facilities, Bulk Pharmaceutical Chemicals.
See www.ispe.org for other guidlines.
As for an exact regulation to quote, it is doubtful that there is one. The FDA's and other agencies' regulations are normally extremely high level and would not cover the welding requirements. Normally they defer to international standards such as ASME and industry norms such as ISPE.
Regards
Daragh
RE: FDA Guidelines for Inspection
Gerald Austin
Iuka, Mississippi
http://www.weldinginspectionsvcs.com