Tag: Sterile drug manufacturing facility audit questionnaire Part 2

Sterile drug manufacturing facility audit questionnaire Part 2

Useful questions for conducting sterile drug manufacturing facility audit. Part 2 The following reference questions are provided for evaluation of specific drug products, manufacturing systems, and quality control procedures in sterile dosage form manufacturing. COMPONENT STORAGE AND PREPARATION 1. Does the firm have adequate written procedures describing the receipt, handling, that are represented to be sterile […]

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