FDA Guidelines for Inspection

[apiguy]

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....

 

[quark]

Not very strict for utilities other than purified water and WFI. If you are performing orbital welding, weld parameters (viz., current, speed of weld head and overlap angle etc) should be maintained. Generally 10% borescoping is ok. Welder qualification certificates should be a part of the documentation. Organ purity certificates form part of the doucmentation. You should also maintain passivation and pipe slope records.

Regards,

 

[apiguy]

Thanks Quark but what I need is the exact reference to an FDA document such as FDA CFR blah blah blah.

The APIGUY....

 

[quark]

Not to my knowledge, atleast. Ironically though we keep racks of records with respect to these piping not a single auditor asked for these. Sometimes, this seems to me as a trick by the suppliers to prove their supremacy over others.

 

[dtreacy]

This is quite a difficult one to answer without additional information as to the exact application, environment, materials and risk to the product.

In general a good reference document is the ISPE Baseline Vol 1. Guideline for new facilities, Bulk Pharmaceutical Chemicals.
See

http://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

 

[pipewelder1999]

Here is a link toa document that may help.

http://www.calair.com/news_ISPE.htm

I am working on a dababase for tracking these welds and the supporting documentation (MTRS,GAs Certs, Receipt Insp Recoords etc.)

Gerald Austin
Iuka, Mississippi

http://www.weldinginspectionsvcs.com