GMP Conformity Assessment
GMP Conformity Assessment Of Overseas Manufacturers Of Therapeutic Products
Regulatory Guidelines and Standards
With effect from 1 April 2004, all new overseas manufacturers who intend to register their therapeutic products in Singapore will be subjected to a GMP Conformity Assessment by HSA.
Manufacturers which have been previously audited and found to conform to GMP standards by a PIC/S member authority or any of the HSA's benchmark GMP inspection authorities may submit GMP evidence e.g. a valid GMP Certificate, for evaluation. Such manufacturers do not need to be audited by HSA if the submitted evidence is found to be acceptable.
Manufacturers who do not meet the above criteria will be subjected to an on-site audit by HSA's GMP auditors to assess their compliance to the PIC/S GMP standard. An application to request for an overseas audit has to be filed together with the submission of a Quality System Dossier, which is essentially a collation of documents and information that provides a comprehensive overview of the manufacturing site, facilities and the quality system of the manufacturing operations.