Quality

Leadership in Quality is one of West’s Core Values, serving as a cultural north star across all areas of our business. Our team members are trained to consider quality each day, in every step of every process. As millions of people globally rely on West’s products, never compromising on quality is a constant focus of ongoing training, auditing and process development.

During our Annual Global Quality Week, our team members were educated on the importance of being proactive versus reactive when it comes to quality; working to control situations and identify future problems as opposed to acting in response. Team members across all areas of the business participated in the interactive, educational Quality Week, with sessions held at West’s Corporate Headquarters, virtually and at manufacturing sites across the globe.

Quality Highlights From Across the Business

Contract Manufacturing & Device

We saw a 5% decrease in Out of Specification complaints from 2022 to 2023.

  • Root Cause Training was rolled out globally to support our proactive approach to quality.

Containment

 We saw a 6% improvement in final reject rates for elastomer manufacturing in 2023 compared to 2022.Out of Specification customer complaints were reduced by 28% in 2023, compared to 2022.

Supplier Quality

  • We established new Supplier Quality processes to proactively drive quality at the supplier level by defining clearer raw material and component requirements and more thorough process validations at suppliers.
  • We realized a 19% reduction in Supplier Corrective Action Requests (SCARs) in the period of May through December of 2023 (since we began measuring).

Annex 1

The 2023 European Good Manufacturing Practice (GMP) Annex 1 revision is causing a major shift in drug manufacturing. The regulations have more than tripled in length with this revision, and they contain over 30 references to primary packaging materials alone. This evolving regulatory landscape requires West’s customers to ensure they are working with a true expert who can help them navigate the new legislation. We believe West is best positioned to be a partner to help our customers deal with these new requirements.

European Union’s (EU) GMP Annex 1 provides technical guidance on the principles and guidelines for sterile injectable drug products for human use and veterinary use. The revision mandates a holistic Contamination Control Strategy in which companies will need to establish and document a process to identify and assess risks and define actions to prevent contamination of sterile products.

Producing high-quality, ready-to-use packaging components has always been a strength of West, and our customers are leveraging our capabilities to support their Contamination Control Strategy, especially as it pertains to this new legislation. Our Quality teams are working directly with other parts of the business to ensure that West’s global Contamination Control Strategies support our customers’ ability to comply with the new Annex 1 guidelines.

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