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Frequently Asked Questions for Combination Products
and Guidance for manufacturers
FDA announced replacement of certain sections of 21 CFR Part 110 Food GMPs with the new regulation 21 CFR Part 117 Current Good Manufacturing Practice
US FDA Guidance Documents
Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
21 CFR 11, 210/211, 820, ICH Q7 - GMP Std Handbook Medical Device Frequently Asked Questions for Combination21 CFR 11, 210 211, 820 QMSR, ICH Q7 GMP Std Handbook: US FDA Title 21 CFR Part 11 Electronic Records; Electronic Signatures and includes Scope and Application 2003 FDA Interpretation of Part 11 Requirements. US FDA Title 21 CFR Parts 210 211 Good Manufacturing Practices The regulations set forth in parts 210 211 contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the
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