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Licensing and Certification of Manufacturers

  1. Responsibilities of Manufacturers

Responsibilities of Manufacturers

Information on the duties and obligations of manufacturers.

Complying with the licence authorisation, standards and conditions

Amongst the duties required of manufacturers, they must:

  • Manufacture the active ingredients according to the authorisation and conditions in the licence
  • Manufacture the active ingredients in compliance with the principles and guidelines of Good Manufacturing Practice standard
  • Provide and maintain, or ensure the provision and maintenance of, the staff, premises, equipment and facilities that are necessary for carrying out the stages of the manufacture, storage and distribution of the active ingredients
  • Ensure that the active ingredients produced is of the correct identity and conforms with the applicable quality standards of quality and purity established
  • Conduct testing to confirm the quality and purity of the active ingredient prior to release for supply 
  • Ensure the proper handling, storage, and distribution of the active ingredients to prevent the deterioration of the active ingredients while they are in the manufacturer’s ownership, possession or control.

You may refer to the Health Products (Active Ingredients) Regulations 2023 for more details.

Maintaining records

Manufacturers of active ingredients must maintain records which include: 

  • Records of the raw materials, intermediates or labelling and packaging materials used in the manufacture of each batch of active ingredients, including the details of the tests or checks performed on those materials
  • The production procedures, instructions, batch records for each batch of active ingredients
  • The quality control procedures and records including the complete data derived from all tests conducted to ensure compliance with established specifications and standards for the active ingredients manufactured and supplied
  • Records of product complaint, defects received and the investigation of these reports

  • Records of receipt and supply of the active ingredients

These manufacturing records and related documents should be maintained for at least 12 months after the expiry date of the active ingredients, or if there is no expiry date, for at least 5 years after completion of the manufacture of the active ingredients. Records of supply or distribution of active ingredients should be maintained for at least 2 years after the date of their supply or distribution.

You may refer to the Health Products (Active Ingredients) Regulations 2023 and the PIC/S GMP Guide for more details.

Notification of significant changes

If you are planning to make significant changes that may impact on the operational activities of the site, including cessation of some of the operations, you are advised to notify HSA via the Health Products Feedback Form.

You may refer to Amend a licence for the different types of amendment.

Notification on recall of active ingredients

Under the Health Products (Active Ingredients) Regulations 2023 (regulation 24), you are required to maintain records of reported or suspected defect in the active ingredient. These records should contain essential information on the identity of the active ingredients, detailed description of the defect, investigation of root causes, any impact assessment performed, and any corrective or preventive actions taken. Such information should be made available to the HSA inspectors as and when required.

If you decided to initiate a recall of the defective active ingredient after reviewing their investigation, the manufacturer is required under the Health Products (Active Ingredients) Regulations 2023 (regulation 25), to notify the HSA before the start of the intended recall.

Please submit the notification recall of defective active ingredients using this form: Notification of Recall for Active Ingredients

For further enquiries about recall of specific lot of active ingredients by local manufacturer, please contact HSA_gmp@hsa.gov.sg.

Notification on planned foreign inspection of local manufacturers

You are requested to notify the HSA of any planned GMP inspection of your manufacturing site by any foreign inspection agency or foreign regulatory bodies by emailing the following information to HSA_gmp@hsa.gov.sg:

  • The name, full address (including e-mail) and phone number of the inspectors from foreign inspection authority
  • The planned inspection date(s) as agreed with the company
  • Purpose and scope of inspection
  • The name and address of the company and the sites in Singapore to be inspected
  • Contact person of the company (name, phone, and e-mail)
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