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.
SITE MASTER FILE (Part 1 of 2)
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Site Master File
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Table of content
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Prepration, Review and Approval
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General information on the manufacturer
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General information on the manufacturer
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General information on the manufacturer
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General information on the manufacturer
Quality Management System
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Quality Management System
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Quality Management System
Personnel
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Personnel
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Personnel
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Personnel
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Premises and equipment
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Premises and equipment
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Premises and equipment
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Premises and equipment
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Premises and equipment
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Premises and equipment
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Premises and equipment
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Premises and equipment
Documentation
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