Manufacturer's Licence for Therapeutic Product
Applicant for a manufacturer's licence of therapeutic products should submit a Site Master File as an attachment together with the required information via online services (PRISM). The Site Master File should be prepared in accordance with PIC/S Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File.
Applicant for a manufacturer's licence of therapeutic products should also familiarize themselves with the following guidance documents provided at this page.
HSA's Guidance Notes on:
1. Audit and Licensing of Pharmaceutical Manufacturers (GUIDE-MQA-002)
2. Good Manufacturing Practice for Assemblers of Medicinal Products (GUIDE-MQA-017)
3. Guidance Notes on Product Quality Review (GUIDE-MQA-024)
PIC/S Guides on:
4. Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File (PIC/S PE 008-4)
5. Recommendation on Sterility Testing (PIC/S PI 012-3)
6. Validation Master Plan, Installation and Operational Qualification, Non-sterile Process validation, Cleaning validation (PIC/S PI 006-3)
7. Validation of Aseptic Processes (PIC/S PI 007-6)
WHO’s Guides on:
8. Water Pharmaceutical Use
9. Good Manufacturing Practices for Heating, Ventilation and Air-Conditioning systems for Non-Sterile Pharmaceutical Dosage Forms