Process Validation: Moist Heat Sterilization for Pharmaceuticals
- Topics:
- Pharmeceuticals
- Tags:
- Benefits,
- Software,
- Pharmaceutical Company,
- Manufacturing,
- Human Resources,
- Healthcare,
- Health Care,
- Health Canada,
- Enterprise Software,
- Vertical Industries
- Source:
- Health Canada
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Overview: This document is intended to provide manufacturers of pharmaceutical dosage forms with guidance to establish the scientific effectiveness of moist heat sterilization processes, as required in Sections C.02.004, C.02.005, C.02.007, C.02.011 and C.02.029 of the Food and Drug Regulations. This guideline is applicable to moist heat sterilization processes only. While the principles outlined in this document are shared with other methods of sterilization, those processes require control and assessment of different parameters. It must be recognized that, regardless of the sterilization process, the control of manufacturing environments and good manufacturing practices which provide barriers to microbial contamination remain of utmost importance.
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Format: PDF | Size: 158KB | Date: May 2001 | Pages: 20
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