Good Manufacturing Practice and Good Distribution Practice Standards

Good Manufacturing Practice Standard

Good manufacturing practice (GMP) is the aspect of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.

As a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), HSA adopts the current version of PE 009 PIC/S Guide to Good Manufacturing Practice for Medicinal Products which is published on the PIC/S website as the GMP standard for:

• Therapeutic Products

• Active Pharmaceutical Ingredients (API)

• Chinese Proprietary Medicines

• Other Medicinal Products, such as medicated oil, balm and medicated plaster

All licensed and GMP-certified manufacturers of these products are required to comply with the current PIC/S GMP Guide which is published on the PIC/S website.

PIC/S GMP Guide

The PIC/S GMP Guide is divided into two parts and a number of annexes which are applicable to both parts. Part I covers the general GMP principles for the manufacture of finished products. Part II covers GMP for active pharmaceutical ingredients (API) used as starting materials. Part II is equivalent to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q7 Guideline. In addition to the requirements of GMP in Part I and II, a series of annexes provide the details on the requirements on specific areas of activity. For some manufacturing processes, different annexes will apply simultaneously (e.g., Annexes on sterile products, radiopharmaceuticals and/or biological products).

• PIC/S GMP Guide (PE 009-17) Introduction

• PIC/S GMP Guide (PE 009-17) Part I (finished product)

• PIC/S GMP Guide (PE 009-17) Part II (active pharmaceutical ingredient)

• PIC/S GMP Guide (PE 009-17) Annexes

Update on changes to PIC/S GMP Guide

Annex 1 - Manufacture of Sterile Medicinal Products  (effective: 25 Aug 2023)

The revised Annex 1 to the PIC/S GMP Guide on the manufacture of sterile products has been published and will enter into force for the sterile products manufacturers on 25 August 2023, except for Section 8.123 relating to design of lyophilisers and associated product transfer and loading/unloading areas which will be effective from 25 August 2024. The Annex has been revised to reflect changes in regulatory and manufacturing environments, clarifying how manufacturers can take advantage of new possibilities deriving from the application of an enhanced process understanding by using innovative tools as described in the ICH Q9 and Q10 guidelines with robust contamination control strategies. For more details on the development of revised Annex 1, please refer to the PIC/S News.

With each revision of the PIC/S GMP Guide, the onus is on licensed or certified manufacturers to be familiar with the latest guidelines and take the necessary steps to ensure their ongoing compliance. The compliance to the latest guidelines will be assessed during inspection.

Other Documents Related to GMP

• Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File (SMF) (PE 008-4, 01 January 2011)

• Guideline On Setting Health Based Exposure Limits For Use In Risk Identification In The Manufacture Of Different Medicinal Products In Shared Facilities (PI 046-1, 01 July 2018)

• Guidelines On The Formalised Risk Assessment For Ascertaining The Appropriate Good Manufacturing Practice For Excipients Of Medicinal Products For Human Use (PI 045-1, 01 July 2018)

• ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Questions and Answer (10 June 2015)

• ICH Q13 Guideline: Continuous Manufacturing of Drug Substances and Drug Products (16 November 2022)

• Guidance on Secondary Packaging of Therapeutic and Medicinal Products (GUIDE-MQA-031) [PDF, 280 KB]

• Guidance on the Licensing, GMP Certification and Inspection of Therapeutic Products Manufacturers (GUIDE-MQA-034) [PDF, 1.09 MB]

More GMP-related guidelines are published on the PIC/S website.

Trending of GMP deficiencies

Good Distribution Practice Standard

Good Distribution Practice (GDP) is a vital component of Quality Assurance. It requires the company to establish a quality system which ensures that products are consistently stored and handled under appropriate conditions as required by the marketing authorisation or product specification.

Compliance to our Guidance Notes on Good Distribution Practice [PDF, 280 KB] is mandatory for all local importers and wholesalers of Therapeutic Products, Chinese Proprietary Medicines, Cell, Tissue and Gene Therapy Products and Active Ingredients intended for the Singapore market. Our GDP auditors will conduct audits on companies in accordance with these GDP standards prior to the issuance of local dealer’s licences.

Note: Our Guidance Notes on Good Distribution Practice is revised on 15 December 2023, primarily to clarify the GDP requirements for the handling of Active Ingredients, under the new Health Products (Active Ingredients) Regulations 2023. Please refer to the Guidance Notes on Good Distribution Practice (with Tracked Changes) [PDF, 261 KB] which reflect the changes made in the latest revision. Underline denotes addition while strike-through denotes deletion.