Articles

Marken’s Robin Marcus discusses innovation in decentralized clinical trials

Bridging Clinical Research Gaps: How Site Augmentation Enhances Trial Success

Streamlining Clinical Trials with Site Augmentation

This case study outlines how a European contract manufacturing organization (CMO) proactively responded to the revised EU GMP Annex 1 regulations, which introduced stricter requirements for sterile drug packaging, contamination control, and quality assurance. Faced with the challenge of selecting the right stopper quality for a diverse customer base while ensuring regulatory compliance, the CMO needed to improve particulate specifications and demonstrate a phased contamination control strategy aligned with Annex 1 expectations.

West Case Study Meeting Annex 1 Regulations

This article answers key questions about the revised EU GMP Annex 1, which sets stricter standards for sterile drug manufacturing, including contamination control strategies, personnel training, and the use of modern barrier technologies like RABS and isolators. It explains the rationale behind the revision, its impact on both new and marketed drugs, and how manufacturers must adapt to meet heightened regulatory expectations.

Most frequently asked question on the revised EU GMP Annex 1 – Volume 1

Manufacturers of sterile medicinal productEntire supply chain  s entered a new era with the August 2023 EU GMP Annex 1 updates, all of which ultimately focus on enhanced public health protection. This article outlines the pharmaceutical manufacturers requirements to develop a comprehensive contamination control strategy that documents their assurance of sterile drug quality and patient safety

How ready are you? Preparing for the impact of EU GMP Annex 1 on primary packaging

This whitepaper by West Pharmaceutical Services explores how pharmaceutical manufacturers and suppliers can confidently navigate the revised EU GMP Annex 1 guidelines for sterile drug production. It outlines the challenges posed by the new requirements—especially around implementing a robust contamination control strategy (CCS)—and shares West’s proactive, data-driven approach to compliance. 

Tackling Compliance with Confidence

 This whitepaper provides a comprehensive overview of how pharmaceutical manufacturers can achieve compliance with the revised EU GMP Annex 1 regulations, which mark a significant shift in the standards for sterile medicinal product manufacturing. Particular emphasis is on a holistic, risk-based approach to contamination control across the entire supply chain.  

Achieving EU GMP Annex 1 compliance through an end-to-end approach to contamination control (Oct 2025)

Nasal drug delivery has been around since the 1950s when it was used for over-the-counter (OTC) decongestants. In the current pharmaceutical industry, it is used across biologics, small, and large molecule applications, and even has potential for neurodegenerative diseases like Alzheimer’s because it can pass the blood-brain barrier and first-pass metabolism.

Executive Summary: Nasal Drug Delivery on the Rise – What’s Next for Pharma?

Discover how Fedegari’s FOB5 is redefining sterilization with compact design, GMP compliance & high-containment capabilities.

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