Quality:
The suitability of either a drug substance or a drug product for its intended use. This term includes such attributes as the identity, strength and purity.
A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on the sound science and quality risk management.
In Simpex pharma we follow the new paradigm emphasizes:
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The quality must be mainly built in and it will not improve by addition of testing and inspection.
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Better utilization of modern science throughout product lifecycle.
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QRM is a key enabler throughout product lifecycle.
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Robust PQS with appropriate knowledge management, assure quality through product life cycle.
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An integrated approach to development, manufacturing and quality for both industry and regulation.
The Quality features and characteristics of quality involve following:
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Control Strategy
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QBD
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Design space
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RTRT
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CMA
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CPP
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CQA
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PAT
Process Flow approach in Simpex pharma is as follows:
