根据中国药典2020、ICH、OECD、ISO 17025和许多其他全球公认的标准,伯朗氏的研究者团队、设施和经验丰富的实验室管理可以提供高质量的工作。
包括:
ICH Q8(R2)Pharmaceutical Development (Aug 2009)
ICH Q9 Quality Risk Management (Nov 2005)
FDA Guidance for Industry:Container Closure Systems for Packaging Human Drugs and Biologics (May 1999)
FDA Guidance to Industry:Metered Dose Inhaler (MDI)and Dry Powder Inhaler (DPI) Drug Product (Nov 1998)
FDA Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products (July 2002)
欧盟:Guideline on plastic immediate packaging materials(2005)
PQRI Recommendation, Safety Thresholds and Best Practices for E/L in Orally Inhaled and Nasal Drug Products (Sep 2006)
ISO 8871-2:2004 Elastomeric Parts for Paternal and for Devices for Pharmaceutical Use
USP General Chapter <381> Elastomeric Closures for Injections
USP General Chapter <661> Containers—Plastics
USP General Chapter <1660> Evaluation of the Inner Surface Durability of Glass Contaniers
USP General Chapter <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems.
USP General Chapter <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging Delivery Systems
EP Chapter 2.9.17 Test for extractable Volume of paternal preparations
European Pharmacopeia (EP) Testing
3.1 Series; Materials Used for the Manufacture of Containers
3.2 Series; Containers
中国药典2020版四部9621,9622
YBB00142002-2015药品包装材料与药物相容性试验指导原则
化学药品注射剂与塑料包材相容性技术指导原则 (2012)
化学药品注射剂与药用玻璃包装容器相容性研究技术指导原则(试行)(2015)
化学药品与弹性体密封件相容性研究技术指导原则(试行 2018-04-26)
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