1. Radiopharmaceutical Production
Site Master File
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2. Site Master File Contents
The Site Master File (SMF) is prepared by the pharmaceutical manufacturer and should contain specific information about the quality management policies and activities of the company, the production and/or quality control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, a Site Master File need only describe those operations, e.g. analysis, packaging, etc.
Contents
Scope of the Site Master File
Contents of the Site Master File
Example Site Master File
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3. Scope of the Site Master File
SITE MASTER FILE (SMF) provides a general overview of the site and its operations.
The Site Master File concept has been developed by PIC/S and has become a standard expectation of inspectors. Following a recent revision of the explanatory notes by PIC/S, it has been proposed that the status of the Site Master File is more formally linked to the regulatory framework.
A more complete description of the site master file requirements can be found in the PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME (PICS) documents here.
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PICS Site Master File

4. Contents of the Site Master File
The Contents of an example site master file as required under the PICS guidelines can be found by following the arrow.
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Site Master File Contents
Another example of the table of contents of a site master file is given on the following pages

5. Contents of the Site Master File
Table of Contents 1. General Information 1.2 Introduction 1.3 Products produced 1.4 Senior Management 1.5 General Information on the site 1.6 Quality Management System 2. Personnel 2.1 Employees 2.2 Organization chart 2.3 Training 2.4 Health and hygiene requirements for personnel Personnel hygiene requirements including clothing Health requirements for personnel
3. Premises and Equipment 3.1 Plans General Location of the Site Site and Building Plan Detailed Building Plans 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

6. Contents of the Site Master File
3.5 Zoning Zoning of Manufacturing classification Non Viable particles Viable particles /settle plates Viable particles /active air sampling Viable particles /contact plates 3.6 Highly toxic, hazardous, sensitizing agents 3.7 Water Water types and sampling points Alert levels for water types Action levels for water types
3.8 Manufacturing Equipment 3.9 Control Laboratory Equipment Maintenance and Calibration
4. Documentation 4.1 General 4.2 SOPs 4.3 Computerized system Production Quality Control Laboratory 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

7. Contents of the Site Master File
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

8. Example Site Master File
An model for the preparation and an example of the site master file can be found by following the arrow
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Model Site Master File
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Example Site Master File

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