The Site Master File (SMF) is a crucial document in pharmaceutical manufacturing, providing a comprehensive overview of a facility’s operations and quality management systems. It serves as a vital tool for regulatory authorities during inspections, offering detailed information about the site’s infrastructure, equipment, and processes. The SMF encompasses aspects like the facility’s layout, production workflows, quality control procedures, and personnel qualifications. It also details the handling of materials, storage conditions, and the measures taken to ensure compliance with Good Manufacturing Practices (GMP). Essentially, the SMF demonstrates a manufacturer’s commitment to maintaining high standards of quality and safety in pharmaceutical production.
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SITE MASTER FILE (Part 2 of 2)
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Documentation
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Production
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Production
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Production
Quality Control
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Quality Control
Distribution, complaint, product defect and Recalls
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Distribution, complaint, product defect and Recalls
Self Inspection
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List of Annexure
Referance
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Abbreviations
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Revision History
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Annexure I
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Annexure I
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Annexure II
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Annexure II
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Annexure III
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Annexure III
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Annexure IV
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Annexure IV
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Annexure V
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Annexure V
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Annexure VI A
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Annexure VI A
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Annexure VI B
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Annexure VI B
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Annexure VII
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Annexure VII
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Annexure VIII
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Annexure VIII
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