Drug Products - Site Master File (SMF)

The drug product SITE MASTER FILE (SMF) is the site’s most important GMP document and provides a general overview of the site and its operations. 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.

Running to over 30 pages, this SITE MASTER FILE template only needs a small amount of site-specific modification before it can be adopted for your operations. All you need to do is enter your site-specific information in the coloured fields that are marked.

It covers the pharmaceutical production facility, which incorporates a wide variety of manufacturing technologies. The SMF template includes all necessary information for the manufacturing of tablets, coated tablets, capsules, ointments, creams, gels, suppositories, suspensions, syrups, inhalers, ampoules, vials and syringes.

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Table of Contents:

1. General Information
1.2 Introduction
1.3 Activities Relevant To The Competent Authority
1.4 Qualified Person(s) And 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 Areas for the manufacturing and packaging of dosage forms
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 plate
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
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 Manufacturing Operations Contracted Out
7.3 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 (last 5 years)
9.2 Inspections conducted by foreign authorities (over 5 years)
9.3 Self-Inspections during the last year

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SKU Drug Products - 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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