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Guidance Documents
Applicant for a manufacturer's licence of medicinal products should submit a Site Master File as an attachment together with the required information via online services (PRISM). For information on the preparation of a site master file, please refer to Guidance Notes on Preparation of a Site Master File. Applicant for a manufacturer's licence of medicinal products should familiarize themselves with the guidance documents provided below.
- GUIDE-01 Preparation of a Site Master File (Last major update 1 Jan 2003)
- GUIDE-02 Audit and Licensing Of Pharmaceutical Manufacturers (Last major update 1 Nov 2002)
- GUIDE-03 Microbiological Monitoring Programme For Manufacturers Of Non-Sterile Products (Last major update 1 Feb 1999)
- GUIDE-04 Sterility Testing (Last major update 1 Jan 2000)
- GUIDE-05 Preparation Of Validation Master Plan (Last major update 1 Jan 2000)
- GUIDE-06 Installation And Operational Qualification (Last major update 1 Jan 2000)
- GUIDE-07 Non-Sterile Process Validation (Last major update 1 Jan 2000)
- GUIDE-08 Cleaning Validation (Last major update 1 Jan 2000)
- GUIDE-09 Validation Of Aseptic Processes (Last major update 1 Jan 2000)
- GUIDE-10 Water Systems For Manufacturers Of Non-Sterile Products (Last major update 1 Oct 2000)
- GUIDE-11 Validation of Terminal Moist Heat Sterilisation (Last major update 1 Nov 2001)
- GUIDE-17 Good Manufacturing Practices For Assemblers Of Medicinal Products (Last major update 1 Nov 2002)
- GUIDE-23 Heating, Ventilating and Air Conditioning (HVAC) System For Manufacturer's Of Oral Solid Dosage Forms (Last major update 15 Oct 2006)
- GUIDE-24 Product Quality Review
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