Blogs

In 21 CFR 211.94 it is stated that “Drug product containers and closures shall not be reactive, additive, or absorptive to alter the safety, identity, strength, quality or purity of the drug beyond the official or established requirements.” While the code makes this statement, and if expanded on in the related FDA Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics (May 1999), there is no prescription offered in how to execute an extractables and leachables evaluation, which is, of course, an essential aspect of demonstrating suitability of container closure systems.

Traditional borosilicate glass vials, while being a long-standing staple in pharmaceutical packaging, can present certain limitations that may pose some challenges to drug manufacturers and healthcare providers.

In August 2022 the European Union revised its guidelines for sterile medicinal products for human and veterinary use. These guidelines came into effect on August 25, 2023. West has compiled the most frequently asked questions about Annex 1 and how it affects sterile drug manufacturers, which will be published across a multi-part series.

This is part three of a three-part series about how recent updates to ICH Q2 and Q14 can be applied to the development and validation of leachables methods. Check out part one focused on the background and history of the updated ICH references and two focused on method development.

In August 2022 the European Union revised its guidelines for sterile medicinal products for human and veterinary use. These guidelines came into effect on August 25, 2023. West has compiled the most frequently asked questions about Annex 1 and how it affects sterile drug manufacturers, which will be published across a multi-part series.

The West Taiwan team was recently awarded the Work-Life Balance Award by the Ministry of Labor, Republic of China (Taiwan). This accolade highlights our ongoing commitment to creating a supportive and flexible work environment that prioritizes the well-being of our team members and fosters a culture of trust and innovation.