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 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 PICS 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.
Contents of the Site Master File More Site Master File Contents The Contents of an example site master file as required under the PICS guidelines can be found by following the arrow. Another example of the table of contents of a site master file is given on the following pages
Contents of the Site Master File Table of Contents1. General Information1.2 Introduction1.3 Products produced1.4 Senior Management1.5 General Information on the site1.6 Quality Management System2. Personnel2.1 Employees2.2 Organization chart2.3 Training2.4 Health and hygiene requirements for personnel2.4.1 Personnel hygiene requirements including clothing2.4.2 Health requirements for personnel 3. Premises and Equipment3.1 Plans3.1.1 General Location of the Site3.1.2 Site and Building Plan3.1.3 Detailed Building Plans3.1.4 Personnel, Material and Product Flows3.2 Production and Packaging Areas3.3 Premises mentioned by building references and activities3.4 Heating, Ventilation and Air Conditioning
Contents of the Site Master File 3.5 Zoning3.5.1 Zoning of Manufacturing classification3.5.2 Non Viable particles3.5.3 Viable particles /settle plates3.5.4 Viable particles /active air sampling3.5.5 Viable particles /contact plates3.6 Highly toxic, hazardous, sensitizing agents3.7 Water3.7.1 Water types and sampling points3.7.2 Alert levels for water types3.7.3 Action levels for water types 3.8 Manufacturing Equipment3.9 Control Laboratory Equipment3.10 Maintenance and Calibration 4. Documentation4.1 General4.2 SOPs4.3 Computerized system4.3.1 Production4.3.2 Quality Control Laboratory4.3.3 Warehousing5. Production5.1 Process Flow5.2 Operations for handling materials and products5.3 Rejected materials and products5.4 Validated Processes
Contents of the Site Master File 6. Quality Control6.1 Release of batches6.2 Brief description of Quality Control System7. Contract manufacture and analysis7.2 Analysis Contracted out8. Distribution, Complaints and Product Recalls8.1 Arrangements for handling complaints and recalls8.2 GMP-related complaints8.3 GMP-related product recalls 9. Regulatory inspections and self-inspections9.1 Inspection conducted by national authorities9.2 Inspections conducted by foreign authorities9.3 Self-Inspections during the last year
Example Site Master File More Model Site Master File More Example Site Master File An model for the preparation and an example of the site master file can be found by following the arrow