Guidance Documents for Industry and Applicants
From 13 September 2016, Audit & Licensing Division has now relocated to 11 Biopolis Way #11-01 Helios Singapore 138667.
- Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for Medicinal Products
- PIC/S PE 008-4: Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File (Last update 1 Jan 2011)
- GUIDE-02 Audit and Licensing Of Pharmaceutical Manufacturers (Last update Dec 2017)
- PIC/S PI 012-3: Recommendation on Sterility Testing (Last update 25 Sep 2007)
- PIC/S PI 006-3: Validation Master Plan, Installation and Operational Qualification, Non-sterile Process validation, Cleaning validation (Last update 25 Sep 2007)
- PIC/S PI 007-6: Validation of Aseptic Processes (Last update 1 Jan 2011)
- GUIDE-10 Water Systems For Manufacturers Of Non-Sterile Products (Last update 11 Jul 2015)
- GUIDE-16 GMP Guidelines For Manufacturers Of Cosmetic Products (Last major update 31 Jan 2018)
- GUIDE-17 Good Manufacturing Practice For Assemblers Of Medicinal Products (Last major update 5 April 2017)
- GUIDE-18 Preparation Of Site Master File For Manufacturer Of Cosmetic Products (Last update 31 Jan 2018)
- GUIDE-019 Preparation of a Quality System Dossier (Last update Dec 2017)
- GUIDE-20 GMP Conformity Assessment of an Overseas Manufacturer (Last update Dec 2017)
- GUIDE-21 Schedule of Service Charges for GMP Conformity Assessment of an Overseas Manufacturer (Last update Dec 2017)
- WHO guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms (Last update 2011)
- GUIDE-24 Guidance Notes on Product Quality Review
- ASEAN Cosmetic Good Manufacturing Practice (GMP) Training Modules
- HPRG Joint Regulatory Workshop 2012 - Updates on PIC/S GMP Standard including Site Master File Guidance
- GUIDE-13 Good Distribution Practice (Last update August 2015)
- GUIDE-22 Guidance Notes on Preparation of a Site Master File for Good Distribution Practice Certification (Last update Jul 2015)
- GUIDE-28 Guidance Notes On Duties Of Responsible Persons Named In The Importer's Licence And Wholesaler's Licence (Last update Nov 2016)
- GUIDE-29 Guidance Notes on Supply of Registered General Sale List (GSL) Therapeutic Products and other Medicinal Products via Automated Vending Machines (Last update Nov 2016)
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