Good Manufacturing Practice Standard
Good Manufacturing Practice Standard
Good Manufacturing Practice (GMP) is a vital component of Quality Assurance to help ensure that therapeutic products and Chinese Proprietary Medicines (CPM) are consistently produced with the quality standards appropriate for their intended use. All manufacturers, including assemblers of therapeutic products and CPM intended for the Singapore market, are required to conform to the GMP standard.
As a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), we adopt the PIC/S Guide to GMP for Medicinal Products (Part I) and its relevant annexes as our current GMP standards. Our GMP auditors will conduct audits on local manufacturers of therapeutic product and CPM for compliance with these GMP standards.
Common non-conformities raised during GMP audits conducted in year 2019 - Classification of GMP Non-Conformities513 KB