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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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