FDA Drug GMP Signature Requirements

The Drug GMPs explicitly require signatures in the following places:

211.186 master prod & control recs

211.182 Equipment cleaning & use logs

211.188 batch prod & control recs

211.194 laboratory recs (perform & review)

Policy guides and enforcements practices indicate that by interpertation FDA expects signatures on specific records and procedures including any places where company procedures require additional signatures/approvals.

If electronic signatures are used for any of these then since they are signatures required by the predicate rule it is clear Part 11 would also apply for Drug Manufacturers.

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