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Introduction
Good Manufacturing Practice & Licensing of Premises
The Good Manufacturing Practice Unit was formed in April 1997 within the National Pharmaceutical Administration (NPA) of the Ministry of Health to centralise the inspection of manufacturers of medicinal and cosmetic products under one specialised unit.
Pharmaceutical manufacturing in Singapore: The Unit has been referred to as the GMP and Licensing Unit, when its scope of work expanded considerably to include the licensing of pharmacies, dealers of medicinal products, including Chinese Proprietary Medicines (CPM), the regulating of psychotropic substances and narcotic drugs in accordance with international drug conventions, and the granting of the Certificate of a Pharmaceutical Product under the World Health Organisation (WHO) Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. With effect from April 2001, Good Manufacturing Practice and Licensing Unit has been upgraded to become the Division of Manufacturing and Quality Audit (MQA) and subsequently in August 2008, the MQA Division had expanded with a GMP Audit Branch, Certification Unit and Good Distribution Practice Audit Unit. The GMP Audit Branch was further divided into Pharmaceuticals Audit Unit, Biologics & Cell and Tissue Therapy Audit Unit, Natural Health Products Audit Unit and Overseas Audit Unit.
Audit & Licensing Division - GMP and GDP Audit
With effect from 1 Dec 2009, Manufacturing & Quality Audit Division had been renamed to Audit & Licensing Division (ALD). The Audit & Licensing Division is comprised of Audits Branch and the Quality Assurance Office. GMP Audit & Licensing Unit, GDP Audit & Licensing Unit, Certification Unit and Overseas Audit Unit are the 4 units that reside under the Audits Branch. The principal function of the Audits Branch is to audit and license pharmaceutical manufacturers and importers/wholesale dealers in accordance with current international Good Manufacturing Practice (GMP) and Good Distribution Practices (GDP) standards respectively. The objective of the audit and licensing activities is to ensure the production of good quality medicines and the preservation of product quality down the supply chain from the manufacturers to the distributors and retailers. Additionally, the new Quality Assurance Office under the ALD is responsible to co-ordinate the implementation of an effective quality assurance framework across various regulatory divisions within HPRG.
Secretariat of QCAC
Audit & Licensing Division is also the Secretariat of the HSA's Quality Control Advisory Committee (QCAC). The terms of reference of QCAC include the provision of advice to the licensing authority on matters relating to GMP and quality assurance of medicinal products.
Licences & Certificates
The types of licences and certificates under the purview of Audit & Licensing Division include:
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