API - Drug Substances - Site Master File (SMF)

The active pharmaceutical ingredient (API) SITE MASTER FILE (SMF) provides a general overview of the site and its operations. A SITE MASTER FILE is prepared by the manufacturer and contains specific and factual GMP information about the production and/or control of API manufacturing operations at the named site and any closely integrated operations in adjacent and nearby buildings. On 5 November 2002, the guidelines for the preparation of a SITE MASTER FILE (first edition, April 2000) were replaced by the PIC/S explanatory notes for industry on the preparation of a site master file, 1 November 2002.

This SITE MASTER FILE has been created in line with current industry standards and is based on guidance from both the European Commission Directorate General III – “Industry” Harmonisation of Inspections in the EU and PIC recommendations.

The 29-page SITE MASTER FILE template only needs a small amount of site-specific modification before it can be adopted in its entirety for your operations. All you need to do is enter your site-specific information in the coloured fields that are marked.

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Table of Contents:

1. General Information
1.2 Introduction
1.3 Products produced, classified by active Substances
1.4 Senior Management
1.5 General Information on the site
1.6 Quality System Management System
2. Personnel
2.1 Employees
2.2 Organization chart and key personnel
2.3 Training
2.4 Health and hygiene requirements for personnel
2.4.1 Personnel hygiene requirements including clothing
2.4.2 Health requirements for personnel
3. Premises and Equipment
3.1 Plans
3.1.1 General Location of the Site
3.1.2 Site and Building Plan
3.1.3 Detailed Building Plans
3.1.4 Personnel, Material and Product Flows
3.2 Production and Packaging Areas
3.3 Premises mentioned by building references and activities
3.4 Heating, Ventilation and Air Conditioning
3.5 Zoning
3.5.1 Zoning of Manufacturing classification
3.5.2 Non Viable particles
3.5.3 Viable particles /settle plates
3.5.4 Viable particles /active air sampling
3.5.5 Viable particles /contact plates
3.6 Highly toxic, hazardous, sensitizing agents
3.7 Water
3.7.1 Water types and sampling points
3.7.2 Alert levels for water types
3.7.3 Action levels for water types
3.8 Manufacturing Equipment
3.9 Control Laboratory Equipment
3.10 Maintenance and Calibration
4. Documentation
4.1 General
4.2 SOPs
4.3 Computerized system
4.3.1 Production
4.3.2 Quality Control Laboratory
4.3.3 Warehousing
5. Production
5.1 Process Flow
5.2 Operations for handling materials and products
5.3 Rejected materials and products
5.4 Validated Processes
6. Quality Control
6.1 Release of batches
6.2 Brief description of Quality Control System
7. Contract manufacture and analysis
7.2 Analysis Contracted out
8. Distribution, Complaints and Product Recalls
8.1 Arrangements for handling complaints and recalls
8.2 GMP-related complaints
8.3 GMP-related product recalls
9. Regulatory inspections and self-inspections
9.1 Inspection conducted by national authorities
9.2 Inspections conducted by foreign authorities
9.3 Self-Inspections during the last year

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SKU API - Drug Substances - Site Master File (SMF)


What you will get: 
Delivery item: Word Document
You will be able to enter your data into the Word document.
Please note: We do not deliver hard copies.


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