Licensing and Certification of Manufacturers

  1. Inspection of Manufacturers

Inspection of Manufacturers

GMP inspection process and standard for manufacturers of active ingredients

All licensed and certified manufacturers of active ingredients must demonstrate compliance to Good Manufacturing Practice (GMP) standard. HSA conducts inspections to determine whether your manufacturing operations are in compliance with the current PIC/S GMP Guide.

If you are setting up a new manufacturing site in Singapore, a pre-approval inspection will be conducted upon receiving the application for a manufacturer’s licence. You should ensure that the manufacturing site is ready for the inspection.

The assigned inspection team will contact you to arrange for a pre-approval inspection of the site within 3 months from the date of application. Pre-inspection information may be requested by the inspection team. The duration of the inspection will vary depending on the complexity of the activities to be assessed.

Following an inspection, a post inspection letter will be issued to you (typically within 15 working days from the last day of inspection). The post inspection letter will state a list of GMP deficiencies classified as critical, major or other and any regulatory non-compliance which are observed during the inspection.

A deficiency is the non-fulfilment of a requirement in the GMP guidelines. The definitions of critical, major or other are based on the definitions in PI040-1 PIC/S Guidance on Classification of GMP Deficiencies and represent the risks to product quality and patient safety.

Manufacturer's response to inspection findings

You are required to respond to all the GMP deficiencies and regulatory non-compliance (if any) by the timeline as stated in the post inspection letter, which is typically within one month from the date of the post inspection letter.

The inspection team will review and provide the assessment on your response, typically within one month from the date of submission of your written response. If your response is unsatisfactory or additional information/clarification is required, the inspection team will inform you via a follow-up letter. You should respond to the follow-up letter(s) within the due date specified in the letter(s).

You are expected to address all the GMP deficiencies and regulatory non-compliance (if any) satisfactorily before the inspection can be closed out and for the licence or certificate to be issued.

A risk-based approach is used to determine the next GMP inspection frequency. This is dependent on the risk classification of the manufacturer, degree of compliance to GMP and other regulatory concerns. You will be informed of the next inspection frequency upon the close-out of the inspection.

Once the inspection is satisfactorily closed out, the licence application will be approved within 10 working days. The manufacturer’s licence is issued electronically via PRISM after approval of the application.