Bulk Production
GMP manufacturing of product for clinical supply: Good Manufacturing Practice, is a set of regulations and
guidelines established by regulatory agencies to ensure the quality, safety, and efficacy of pharmaceuticals,
including those used in clinical trials. The following are some of the key considerations to be taken into
account
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Facility compliance and validation
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Documentation/ SOP training
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Supply chain management
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Batch records and stock maintenance
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Compliance audit
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Regulatory submission