Regulatory Compliance Resources for Laboratories
Interested in learning more about compliance and regulatory issues? Some helpful resources for GLP, GMP, cGMP, warning letters and other topics include:
FDA - US Food and Drug Administration
CDER - Center for Drug Evaluation and Research
CBER - Center for Biologics Evaluation and Research
ORA - Office for Regulatory Affairs
Highlights within these websites for regulatory compliance information include:
FDA Investigations Operations Manual. The IOM is the primary guidance document on FDA inspection policy and procedures for field investigators and inspectors.
Compliance Program Guidance Manual, which provides a numerical listing of all FDA Compliance Programs with hyperlinks to those available electronically on FDA websites, organized by these program areas:
- Biologics
- Bioresearch Monitoring (BIMO)
- Devices/Radiological Health
- Drugs
- Food and Cosmetics
- Veterinary Medicine
483 Forms, where 483 notices are published online in the FDA's Office of Regulatory Affairs Reading Room.
Warning letters are available in two locations on the government website, either posted in the FDA's Electronic Freedom of Information Reading Room, where you can search Warning Letters and Responses or via the Center for Drug Evaluation and Research (CDER) section devoted to Warning Letters. The letters are arranged in chronological order by year and month.
News at the FDA includes press releases; the weekly Enforcement Report; and links to the Office of Regulatory Affairs news.
Office of Regulatory Affairs main home page offers access to information from ORA, the lead office for all field activities of the Food and Drug Administration. It includes a Reference section with links to ORA's Compliance Reference, Inspection Reference and Science Reference.
Specific information at the ORA site includes information about Title 21 Code of Federal Regulations (21 CFR Part 11) Electronic Records and Electronic Signatures, including updates and background information.