PPS has developed structured technology transfer layout encompassing every aspect of the production process in detail and in compliance with GMP regulation.
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Documentation- We provide a complete master plan containing detailed description of all process methods, analytical methods and SOPs.
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Cell banking- master cell bank and working cell bank methods of preparation
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Uspstream- Fermentation and harvest
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Downstream-Extraction, solubilization, refolding, chromatography and ultrafiltration
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Final dosage form
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Quality control
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Product specification
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stability data- IB fraction stability, hold points stability, FDF stability
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Validations- shipment conditions validation, equipment validation
- Lab scale verification
- Health/Safety/Environment
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