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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.

This is part two of a three-part series about how recent updates to ICH Q2(R2) and Q14 can be applied to the development and validation of leachables methods. You can find part one here.

In today’s rapidly evolving business landscape, the need for skilled workers has never been greater. West has risen to this challenge by not just hiring talent, but also molding it through effective apprenticeship programs in collaboration with the Pennsylvania College of Technology (Penn College), a special mission affiliate of Pennsylvania State University. These initiatives have proven to be a resounding success.

Since 25 August 2023, the revised European Union guidelines for Good Manufacturing Practice (EU GMP) Annex 1 has imposed requirements to implement a Contamination Control Strategy (CCS) across the facilities of finished drug product manufacturers, to ensure higher quality and sterility of medicinal products for human and veterinary use.

Part I – Background and History
The final step in the drug packaging extractables and leachables (E&L) journey is the determination of the actual leachables that are observed in the drug during the product’s shelf life. This is typically determined with a leachables stability study that incorporates accelerated and normal storage conditions, with the results of the accelerated conditions often being used to support a regulatory submission. However, before any of these activities take place, methods to determine a wide range of potential leachables (organic and inorganic) need to be developed and validated for this specific use.