print small large

This application is a service of the Singapore Government.

Health Sciences Authority

Guidance Documents

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