Health Sciences Authority - GMP and GDP Standard

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Good Manufacturing Practices Standards and Good Distribution Practice Standards

Good Manufacturing Practice Standard

Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for Medicinal Products

Good Manufacturing Practice (GMP) is a vital component of Quality Assurance which helps to ensure that medicinal products are consistently produced with the quality standards appropriate for their intended use. Under the Medicines Act, all manufacturers and assemblers of medicinal products (both "Western Medicines" and "Chinese Proprietary Medicines" (CPM)) are required to conform to GMP. As a member of PIC/S, HSA's GMP auditors will conduct audits on medicinal product manufacturers and assemblers in accordance with the PIC/S Guide to GMP for Medicinal Products (Part I) and its relevant annexes, which encompasses all the recommendations of the World Health Organisation (WHO) in relation to GMP. The PIC/S Guide to GMP for Medicinal Products may be downloaded from PIC/S website.

With effect from 1 April 2004, all new overseas manufacturers who intend to register their "western" medicinal products in Singapore are expected to meet the PIC/S GMP standard (or other equivalent standards). Further information can be found at GMP Conformity Assessment of Overseas Manufacturers of Medicinal Product.

Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) Good Manufacturing Practice (GMP) Guide For Active Pharmaceutical Ingredients

All Active Pharmaceutical Ingredients (API) manufacturers who are applying for a GMP Certificate from HSA are expected to conform to the PIC/S Guide to GMP for Medicinal Products (Part II) HSA's GMP auditor will conduct a GMP certification audit in accordance with this standard which may be downloaded from the PIC/S website. The application for a GMP Certificate is non-mandatory.

Health Sciences Authority GMP Guidelines for Manufacturers of Cosmetic Products

In accordance to the Medicines (Good Manufacturing Practice Certificate - Cosmetic Products) Regulations, all manufacturers of cosmetic products in Singapore may apply for a GMP Certificate from HSA. HSA's GMP auditor will conduct a GMP certification audit in accordance with the "HSA GMP Guideline for Manufacturers of Cosmetic Products" which encompasses all the recommendations of the ASEAN Cosmetic Directive in relation to GMP. The application for a GMP Certificate is non-mandatory.

With the joint effect of the regulatory authority and the industry of the ASEAN member counteries, a set of 13 training modules on the ASEAN cosmetic GMP have been developed to provide a consistent interpretation and implementation of the GMP Guidelines in ASEAN. The training modules can be obtained from the ASEAN official website: http://www.aseansec.org/18514.htm. The information may also be requested from the local cosmetic association.

Good Distribution Practice Standard

Good Distribution Practice is a vital component of Quality Assurance. It requires the company to establish a quality system to ensure that products are consistently stored and handled as required by the marketing authorization or product specification, thereby maintaining the quality of the products during storage, transportation and distribution. HSA's auditors will conduct audits on the company in accordance to the HSA Guidance Notes on Good Distribution Practice.

In response to feedback received from the industry for requirements related to the handling of temperature-sensitive products (also known as cold chain products) to be made clearer, the HSA Guidance Notes on Good Distribution Practice has recently been revised to include guidelines on the control and management of such products. Sections of the guidelines pertaining to the handling of cold chain products were revised based on established international standards and industry best practices.

In acknowledgement of the time that may be required for companies to be fully compliant with the requirements for the handling of cold chain products as stipulated in the revised guidelines, there will be a transition period from Sept 2010 to end May 2011. During this transition period, any gaps identified during the GDP audits related to the control and management of cold chain products would be issued as recommendations and companies are expected to provide the audit team with a plan of implementation to close the gaps identified. However, during this transition period, companies are still expected to comply with all other requirements as stipulated in the guidelines. With effect from 1 Jun 2011 onwards, companies are expected to be fully compliant with all the requirements of the guidelines, including those for cold chain management.

Jan' 10 – Apr' 10	May' 10	Jun' 10 – Aug' 10	Sept' 10 – May' 11	1 Jun 2011 onwards
Revised guidelines (Draft).	Final draft for industry comments.	Consolidation of feedback & comments, and finalization of guidelines.	Transition Period – Audit based on revised standards. Gaps issued as recommendations, and companies to give plan of implementation.	Compliance with revised standards.

Last updated on 03 Sep 2010 17:19:33