batch records
- Guideline or reference source
- ECA GAMP5 Approach and Risk Management
- WHOGMP Quality assurance of pharmaceuticals volume 2
- Definition
- All documents associated with the manufacture of a batch of bulk product or finished product. They provide a history of each batch of product and of all circumstances pertinent to the quality of the final product.
- Narrower Term
- manufacturing batch record
- packaging batch record
- Related Term
- batch
- master record
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