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Home >> About PBL >>Quality Systems >> Regs and Standards

QUALITY SYSTEM: Regulations and Standards

STANDARDS AND REGULATIONS

The following link takes you to a company that has translated some ISO standards into Plain English:

http://www.praxiom.com/

The following link takes you to the Internationals Standards Organization where you can immediately purchase the actual standards:

http://www.iso.ch/iso/en/ISOOnline.frontpage

Here are links to FDA regulatory standards that apply to Quality Assurance or Quality Control. This is certainly not all the regulations with which PBL is familiar or that we can accommodate. Our customers most frequently request help for these requirements.

If you are making a drug or pharmaceutical, this link takes you to the cGMPs (21CFR211):

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211

If you are making (or want to make) a biological product, this link takes you to the FDA Quality requirements (21CFR610):

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=610

If you are making (or want to make) a medical device, this link takes you to the FDA Quality System Requirements (QSR 21CFR820):

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820

If you are haven’t made any products yet, but want to have the FDA approve them, here is a link to the FDA requirements for Good Laboratory Practices (GLP  21CFR58):

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58

If you would like to learn more about the FDA's guidance for inspections and field activities, you can find information at the following link.

http://www.fda.gov/ICECI/Inspections/default.htm

 

 
 
 
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