Global Equivalents and Related Regulations
Global Equivalents to 21 CFR Part 11
EMEA Guidelines to Good Manufacturing Practice: Annex 11 (European Union)Part 11 and Annex 11 provide detailed information on generating and storing electronic data generated in the course of GXP laboratory or manufacturing work. Annex 11 offers a guide to operating in a compliant GXP space, while Part 11 is a list of prohibitions, but they are largely harmonized. Notable differences include how individuals must be identified and expectations regarding personal liability for use or misuse of secure access.
ERES Guideline: Application for Approval of Licensing of Drugs (Japan)Japanese guidelines for generating and storing electronic records closely match the intent of U.S. Part 11. Companies closely adhering to 21 CFR 11 will be in compliance with the ERES guideline, but Japanese companies will need to take precautions to fully adhere to Part 11 for products sold in the U.S.
Food & Drugs Act, Division C.02 (Canada)Canadian regulations are written to place the responsibility for compliance on the individual where U.S. Part 11 regulations provide a series of requirements without specifically identifying responsible parties. The Canadian guidelines also account for Mutual Recognition Agreements (MRAs) with countries whose standards are of equivalent scope and depth. MRAs allow for more rapid import and approval of raw materials and finished products across borders.
Related Codes, Regulations & Guidance Documents21 CFR provides extended guidance for application of good manufacturing practice (GMP, 21 CFR 210 and 211) and good laboratory practice (GLP, 21 CFR 58) as well as the production of biological products (biologics) including:
21 CFR 210-211: Guidelines for cGMP manufacturing, processing, packing, or holding drugs and finished pharmaceuticalsFor cleanroom operators, 21 CFR Parts 210-211 underscore the importance of validated quality controls for all steps in the production workflow including air-quality monitoring. All work pertaining to the production and packaging of drugs must be conducted and recorded in compliance with written SOPs. All records pertaining to the production of a drug will be reviewed annually. As noted in Part 11, personnel engaged in drug manufacturing and packaging must have adequate and ongoing training and education to perform their assigned functions in a cGMP setting.
21 CFR 58: Guidelines for cGLP non-clinical laboratory studiesFor cleanroom operators (including CROs) this guideline defines quality assurance requirements for active surveillance of compliance to SOPs and record-keeping. All data and documents generated as part of cGLP activities must be properly recorded and maintained for regular review. All records are subject to inspection by the FDA.
21 CFR 600: Guidelines for the manufacture and distribution of biologicsFor cleanroom operators, 21 CFR Part 600 provides predicate guidance to 21 CFR 11 regarding records retention. All records relative to biologics manufacturing must contemporaneously capture all steps as they occur, including air-quality monitoring. The record should include who conducted the air-quality audit, the date and time of the audit and any discursions (and associated rationale) from the SOP.
PIC/S Annex 11 – PI 011-3: Good Practices for Computerised Systems in Regulated GxP Environments (2007 )
U.S. FDA: General Principles of Software Validation; Final Guidance for Industry and FDA Staff (2002 )