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Several important changes have been made recently in the United States Pharmacopoeia (USP): Chapter <381> was amended and new chapters <382>, <1382>, and <1381> were created. West has been aware of these changes and is prepared to address them from both a knowledge and a technology perspective.
Key elements of these changes are:
As a result, West is making changes to related quality certificates, which currently provide results for USP/EP combined chemical testing. As heavy metals and zinc belong to chemical testing, the reference to USP will be removed; testing will continue following EP 3.2.9 (Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders and for Freeze-Dried Powders). <381> heavy metals and zinc update will be effective 01-Dec-2020; functional testing will continue harmonization with EP 3.2.9 until the 2025 expiration.
Specific West components will be evaluated to demonstrate USP <382> compliance. Additionally, West will offer product packaging and delivery systems contract testing services for <382> compliance and <1382> compatibility through its Integrated Solutions platform. For more information, watch West's On-Demand webinar.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.