VALIDATION.pptx
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The document discusses quality control and assurance in pharmaceutical manufacturing. It notes that quality management systems provide documented evidence that facilities, equipment, operating procedures, and formulations will consistently produce drugs that meet pre-determined specifications and quality standards. This includes analytical test procedures, instrument calibration, critical support systems, operators, raw materials, packaging materials, equipment, facilities, manufacturing stages, product design, validated processes and more.
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VALIDATION.pptx
- 1. Tejas B patel Assistant Professor Faculty of pharmacy DDU
- 2. It is a tool with which it provide document evidence that the facilities we are built equipments, we operate standard operating procedures and manufacturing formulary, we follow , will consistently produce products that meet the predetermine specification and quality attributes.
- 3. AnalyticalTest Procedure Instrument Calibration Critical Support System Operators Raw materials Packaging Materials Equipment Facilities Manufacturing Stage Product Design Validated Process