bulk production batch
- Guideline or reference source
- EUGMP annex16
- Definition
- A batch of product, of a size described in the application for a marketing authorisation, either ready for assembly into final containers or in individual containers ready for assembly to final packs. (A bulk production batch may, for example, consist of a bulk quantity of liquid product, of solid dosage forms such as tablets or capsules, or of filled ampoules).
- Related Term
- production batch
Send comments to info@qdossier.com Please read disclaimer before using Qsauri.