master production documents
- Guideline or reference source
- HCGMP Canada GMP guidelines 2009
- Definition
- Documents that includes specifications for raw material, for packaging material and for packaged dosage form; master formula (including composition and instructions as described in the definition above), sampling procedures, and critical processing related standard operating procedures (SOPs), whether or not these SOPs are specifically referenced in the master formula.
- Related Term
- master formula
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