finished product batch
- Guideline or reference source
- EUGMP annex16
- Definition
- with reference to the control of the finished product, a finished product batch is defined in Part 1 Module 3 point 3.2.2.5 of Directive 2001/83/EC2 and in Part 2 section F 1 of Directive 2001/82/EC. In the context of this annex the term in particular denotes the batch of product in its final pack for release to the market.
- Related Term
- certification of the finished product batch
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