Safety and stability testing services are an essential part of the development and manufacturing of pharmaceutical products. These tests help to ensure that pharmaceutical products are safe, effective, and stable throughout their shelf life.
Pharmaceutical products are also tested for purity, identity, and strength to ensure that they meet regulatory requirements and are safe for use. Certified laboratories using validated methods and equipment to conduct these tests.
In addition, the Department of Health (DoH) regulates advanced therapy products (ATPs) including gene therapy products, cell therapy products, and tissue-engineered products under the Pharmacy and Poisons Ordinance 2020. The regulation of ATPs in Hong Kong involves a risk-based approach, where the level of regulatory oversight is determined by the level of risk associated with the product.
To ensure the safety, quality, and efficacy of ATPs, the DoH requires that ATPs undergo a comprehensive evaluation process before they can be authorized for use in Hong Kong. We are an accredited laboratory to provide microbial safety tests including method validation for ATPs according to the requirement of the Department of Health of Hong Kong. Our service includes sterility test (USP 71, BP Appendix XVI A, EP Chapter 2.6.1), microbiological examination for examination of cell-based preparation (BP Appendix XVI E, EP Chapter 2.6.27), bacterial endotoxin testing, microbial identification and strain typing, etc.
