Good Manufacturing Practice audits
Compliance to the HSA Guidelines on Good Manufacturing Practice (GMP) for CTGTP is mandatory for a manufacturer of a CTGTP, including those conducting secondary packaging.
Before submission of your application, your company should ensure that it is ready for the audit. Upon acceptance of your application, we will contact your company to arrange for a pre-approval audit within 3 months. A manufacturer's licence will be approved and issued 10 working days from the date of audit close-out.
Your company's Site Master File (SMF) should be prepared in accordance with the Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File (SMF) available from the PIC/S Publication website.
After licence approval, regular routine GMP audits will be conducted to assess your company's continued compliance. The frequency of the routine GMP audits will depend on risk factors like the activities conducted by your company, and your level of compliance with the regulatory requirements. Unannounced GMP audits may also be conducted.