EudraLex Volume 4: EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 16: Certification by a Qualified Person and Batch Release¶
European Commission. (2015). EudraLex Volume 4: EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 16: Certification by a Qualified Person and Batch Release: EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 16: Certification by a Qualified Person and Batch Release.
Cited by¶
1 citation across 1 artifact.
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Mechanisms¶
- Batch Release Gate
- The gate is the last place a bad-sized release can be caught before its cost is realized, and the regulatory world formalizes exactly this: batch release under good-manufacturing-practice requires a designated authority to certify a lot against defined conditions before it can be sold
This sourceRequires a Qualified Person to certify a medicinal-product batch against defined GMP conditions before it enters saleable stock.
- The gate is the last place a bad-sized release can be caught before its cost is realized, and the regulatory world formalizes exactly this: batch release under good-manufacturing-practice requires a designated authority to certify a lot against defined conditions before it can be sold
Verification¶
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Does it back the claim? Not recorded. The single citation of this work carries no recorded support check.
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Registry ID ref:229c35c24ade · see in the full table