Manufacturer's Licence for Therapeutic Product (TPML)
A Manufacturer's Licence for Therapeutic Product (TPML) is required in Singapore if your company intends to manufacture or assemble any therapeutic products. Here's a breakdown of key points about TPMLs:
Requirement: Mandatory for any local facility engaged in manufacturing/assembling therapeutic goods. [HSA Singapore]
Process: Application for TPML is granted after a successful audit confirming compliance with Good Manufacturing Practice (GMP) standards. [HSA Singapore]
Benefits of holding a TPML:
Wholesale exemption: You can wholesale the therapeutic products your company manufactures without a separate license (TPWL). [HSA Singapore]
Import exemption: No need for a Therapeutic Product Importer's License (TPIL) to import necessary materials for manufacturing under your TPML. [HSA Singapore]
Form A Poisons License exemption: Import and store poisons for TPML-compliant manufacturing without a Form A Poisons License (FAPL). [HSA Singapore]
Application Process
Some general pointers of the application process for a Manufacturer's Licence for Therapeutic Product (TPML) in Singapore:
Compliance with GMP first: Before applying for a TPML, ensure your manufacturing facility adheres to Good Manufacturing Practice (GMP) standards. The HSA audits for GMP compliance during the TPML application process. HSA Singapore
Consult the HSA: The HSA offers guidance documents or application forms specifically for TPMLs. You can try contacting the HSA directly for clarification on the application process. Their contact details are available on their website. HSA Singapore
Here are some additional resources that might be helpful:
Guidance on Therapeutic Product Registration in Singapore (TPB-GN-005-012): This document provides a comprehensive overview of the therapeutic product registration process in Singapore, though it may not directly address TPML applications, it might offer valuable insights into the HSA's general approach (https://www.hsa.gov.sg/therapeutic-products/guidance-documents).
By combining these steps and resources, you should be able to gather the necessary information to proceed with your TPML application in Singapore.
Good Manufacturing Practice (GMP) standards
In Singapore, Good Manufacturing Practice (GMP) standards are enforced by the Health Sciences Authority (HSA) and are crucial for obtaining a Manufacturer's Licence for Therapeutic Products (TPML). Here's a closer look at GMP in Singapore:
What are GMP Standards?
GMP is a system of guidelines that ensure consistent quality and safety in the manufacturing process of certain products, particularly those related to health. By adhering to these standards, manufacturers can minimize risks of contamination, errors, or inconsistencies during production.
GMP Standards in Singapore
The HSA aligns with the PIC/S Guide to Good Manufacturing Practice for Medicinal Products, published by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). This ensures international compliance for Singaporean manufacturers. The PIC/S Guide covers various aspects of manufacturing, including:
Quality Management System: Defines a structured approach to ensure quality throughout the process.
Personnel: Ensures proper training and qualification of staff involved in manufacturing.
Premises and Equipment: Establishes requirements for maintaining a clean and well-maintained manufacturing environment.
Documentation: Mandates proper documentation practices for traceability and record-keeping.
Production: Outlines procedures for production processes to minimize errors and ensure product consistency.
Quality Control: Defines practices for testing and ensuring the quality of raw materials, finished products, and in-process materials.
Benefits of Adhering to GMP:
Enhanced Product Quality: GMP helps ensure consistent quality and safety of manufactured therapeutic products.
Reduced Risks: By minimizing errors and contamination, GMP helps protect consumer health.
Regulatory Compliance: Compliance with GMP is mandatory for obtaining a TPML and exporting therapeutic products.
Adhering to GMP is essential for ensuring the quality and safety of therapeutic products in Singapore. By following these guidelines, manufacturers can gain a competitive edge and ensure consumer trust in their products.
Resources:
For more information on TPMLs and the application process, refer to the official resources of the Health Sciences Authority (HSA) Singapore: HSA Singapore
HSA GMP Standards: While the HSA doesn't directly publish the PIC/S Guide, their website provides information on GMP and Good Distribution Practice (GDP) standards: https://www.hsa.gov.sg/therapeutic-products/dealers-licence/gmp-gdp
PIC/S Guide to Good Manufacturing Practice for Medicinal Products: You can find the latest version of the PIC/S Guide on their website: https://picscheme.org/en/publications
How Bestar can Help
Bestar could provide consultancy services to guide you through the TPML application process in Singapore. This might involve reviewing your manufacturing setup for GMP compliance, helping prepare necessary documentation, and liaising with the HSA during the application.
To find out how Bestar can help:
By providing details about your manufacturing setup and goals, we can give you more specific advice on how we can assist you.
Comments