Radiopharmaceutical Production Site Master File STOP Site Master

Radiopharmaceutical Production Site Master File STOP

Site Master File • 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 STOP

Scope of the Site Master File Radiopharmaceutical Production • Site Master File • Contents Scope of the Site Master File Contents of the Site Master File Example 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. More STOP PICS Site Master File

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

Contents of the Site Master File Radiopharmaceutical Production Site Master File Contents Scope of the Site Master File Contents of the Site Master File Example Site Master File STOP 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 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

Contents of the Site Master File Radiopharmaceutical Production Site Master File Contents Scope of the Site Master File Contents of the Site Master File Example Site Master File STOP 3. 5 Zoning 3. 8 Manufacturing 3. 5. 1 Zoning of Manufacturing Equipment classification 3. 9 Control Laboratory 3. 5. 2 Non Viable particles Equipment 3. 5. 3 Viable particles /settle 3. 10 Maintenance and plates Calibration 3. 5. 4 Viable particles /active 4. Documentation air sampling 4. 1 General 3. 5. 5 Viable particles /contact 4. 2 SOPs plates 4. 3 Computerized system 3. 6 Highly toxic, hazardous, 4. 3. 1 Production sensitizing agents 4. 3. 2 Quality Control 3. 7 Water Laboratory 3. 7. 1 Water types and 4. 3. 3 Warehousing sampling points 5. Production 3. 7. 2 Alert levels for water 5. 1 Process Flow types 5. 2 Operations for handling 3. 7. 3 Action levels for water materials and products types 5. 3 Rejected materials and products 5. 4 Validated Processes

Radiopharmaceutical Production Site Master File Contents Scope of the Site Master File Contents of the Site Master File Example Site Master File STOP 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

Radiopharmaceutical Production Site Master File Example Site Master File An model for the preparation and an example of the site master file can be found by following the arrow Contents Scope of the Site Master File Contents of the Site More Model Site Master File Example Site Master File More STOP Example Site Master File

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