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This application is a service of the Singapore Government.

Health Sciences Authority

Guidelines on Good Manufacturing Practice Standard and Good Distribution Practice Standard

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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 therapeutic products and Chinese Proprietary Medicines (CPM) are consistently produced with the quality standards appropriate for their intended use. Under the Health Products Act and the Medicines Act, all manufacturers and assemblers of therapeutic products and CPM are required to conform to GMP. As a member of PIC/S, HSA's GMP auditors will conduct audits on therapeutic products and CPM 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 therapeutic 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 Therapeutic Products.

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 auditors 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 Health Products (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 auditors will conduct a GMP certification audit in accordance with the "GMP Guidelines 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 countries, 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. The information may also be requested from the local cosmetic association.

Good Distribution Practice Standard

Good Distribution Practice (GDP) 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.

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NOTICE OF REVISION OF GUIDANCE NOTES ON GOOD DISTRIBUTION PRACTICE

The Health Sciences Authority (HSA) wishes to notify all companies who practice Good Distribution Practice that we have reviewed and revised the Guidance Notes on Good Distribution Practice. The revised Guidance Notes on Good Distribution Practice (Version 10) has been updated mainly to provide clarity to the existing requirements.

For easy reference, the revised Guidance Notes with track changes is available at the following hyperlink:

HSA Guidance Notes on Good Distribution Practice (Version 10) with Track Changes

If further clarification(s) is/are required on the revised Guidance Notes on Good Distribution Practice, please contact the Good Distribution Practice Unit by e-mail at hsa_gdp@hsa.gov.sg or Tel. No. at 6866 3591/ 6866 3508.