master formula
- Guideline or reference source
- ECA GAMP5 Approach and Risk Management
- HCGMP Canada GMP guidelines 2009
- WHOGMP Quality assurance of pharmaceuticals volume 2
- Definition
- A document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls.
- Related Term
- master production documents
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