安全性和稳定性测试服务是药剂制品开发和制造必不可少的组成部分。这些测试有助于确保药物在整个保质期内安全、有效和稳定。
药品也经过纯度、特性和强度测试，以确保它们符合监管要求并且可以安全使用。 这些测试通常由经过认证的实验室使用经过验证的方法和设备进行。
此外，卫生署（DoH）根据《2020年药剂业及毒药条例》监管先进治疗产品（ATP），包括基因治疗产品、细胞治疗产品和组织工程产品。香港对ATP的监管涉及风险-基于方法，其中监管监督的程度由与产品相关的风险程度决定。
为了确保 ATP 的安全、品质和功效，卫生部要求 ATP 在获准在香港使用之前经过全面的评估流程。 我们是经认可的实验室，可根据香港卫生署的要求提供微生物安全测试，包括 ATP 的方法验证。 我们的服务包括无菌检测（USP 71、BP 附录XVI A、EP 第2.6.1 章）、检查细胞制剂的微生物学检查（BP 附录XVI E、EP 第2.6.27 章）、细菌内毒素检测、微生物鉴定和应变分型等
There are a number of chemicals that are commonly tested in cosmetic products to ensure their safety and compliance with regulations. Some of the most commonly tested chemicals include:
1. Preservatives: These are added to cosmetic products to prevent the growth of bacteria and fungi. Common preservatives include parabens, formaldehyde releasers, and quaternary ammonium compounds.
2. Fragrances: These are added to enhance the scent of cosmetic products. However, some fragrances can cause allergies and other adverse reactions in some people.
3. Heavy metals: These include lead, mercury, and arsenic, which can be harmful if they are present in high levels in cosmetic products.
4. UV filters: These are added to protect the skin from the harmful effects of UV radiation. Common UV filters include octinoxate, avobenzone, titanium dioxide (TiO2), etc.
5. Phthalates: These are often used as plasticizers in cosmetic products and have been linked to adverse health effects.
6. Formaldehyde: This is a preservative that can cause allergies and other adverse reactions in some people.
These are just a few examples of the chemicals that are commonly tested in cosmetic products. Testing for these chemicals helps to ensure that cosmetic products are safe for use and meet regulatory requirements such as Regulation (EC) N° 1223/2009, Title 21 of the Code of Federal Regulation (FDA 21 CFR) Modernization of Cosmetics Regulation Act of 2022 (MoCRA), Cosmetic Supervision and Administration Regulation (CSAR), etc.
