The key pharmaceutical manufacturing regulations include the European Union’s Good Manufacturing Practice (GMP) guidelines and the U.S. Food and Drug Administration’s (FDA) 21 CFR parts 210 and 211. Medical device manufacturers must also comply with relevant requirements, such as EU IVDR 2017/746 and FDA 21 CFR part 820. To demonstrate compliance with these regulations, manufacturers must maintain records in accordance with FDA 21 CFR part 11 and EU Annex 11.

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