Most frequently asked questions on the revised EU GMP Annex 1: Volume 7

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.

1. What are some of the key elements to be considered within a contamination control strategy?

Some of the key elements to consider within a CCS include:

• Facility and Process Design:

  Contamination control starts with manufacturing environments that support cleanability, unidirectional flow of materials, and segregation of high-risk activities. HVAC systems to pressure differentials must be engineered to reduce opportunities for cross-contamination.

• Equipment and Utilities:

  All equipment, from isolators to autoclaves, must be designed to prevent contamination. Clean-in-place (CIP), sterilize-in-place (SIP), and validated cleaning procedures play a central role.

• Personnel Practices:

  Human intervention remains a primary contamination risk. The CCS must address gowning, aseptic techniques, training, and behavioural expectations. Barrier technologies further reduce risk by limiting direct human interaction with critical zones.

• Cleaning and Disinfection:

  Validated cleaning procedures are vital to control both viable and non-viable contaminants. The CCS should ensure that cleaning agents are appropriately selected, effective against relevant bioburden, and applied in a manner that avoids residue buildup or cross-contamination.

• Environmental and Process Monitoring:

  A data-driven monitoring strategy—covering air, surfaces, personnel, and process points—enables early detection of contamination risks. The CCS should define alert/action levels, trending methodologies, and investigation protocols for excursions.

• Product and Material Control:

  The CCS must account for raw materials, excipients, packaging components, and in-process materials. This includes their sampling, storage, transfer, and protection, especially during aseptic processing.

• Risk Management and Continuous Improvement:

  Using formal risk assessment tools the CCS must identify and prioritize control points, inform process design, and drive preventive action with ongoing reviews to support continual improvement.

• Qualification and Validation:

  All critical systems and processes must be qualified and validated with contamination control in mind providing evidence that control measures are effective and reproducible.

A CCS isn’t about isolated checklists—it’s an extensive connection across people, process, and technology, which doesn’t happen with the flick of a switch. At West, we developed and approved a master CCS, which was implemented as an Enterprise Standard Operating Procedure (ESOP). This has been vital in providing local teams with a centralized framework for creating site-specific plans that address previously identified improvement areas, bringing everything in line with a unified system of controls that cover manufacturing, from equipment and environment to processes and personnel.

From these foundations, we envision a future underpinned by continuous improvement. We can evaluate the data being continuously accrued in our knowledge management systems, comparing it against internal and external benchmarks to gain valuable insights into areas where further iterations and enhancements can be made. This evolution of process controls delivers ongoing improvement in a sustainable way.

Crucially, the developments we have made around CCS ensure that, as a trusted supplier, our products and services can dovetail comparatively seamlessly into a pharmaceutical manufacturer’s own approach to compliance. From supporting documentation to strategies for supply and logistics, we understand how to form part of an integrated, collective approach to contamination control. For partners, that not only provides the expected assurances of product quality but also helps ease the burden of adjusting to the exacting demands of Annex 1 by themselves.

2. How is West approaching compliance with the new Annex 1 guidelines?

As a key partner to the pharmaceutical industry, we recognize the significance of EU GMP Annex 1 and its impact is felt throughout the entire supply chain. Whilst the responsibility for compliance sits with the drug product manufacturer, compliance requires contributions from all stakeholders. This is particularly true regarding the adoption of an effective Contamination Control Strategy (CCS). Consequently, West has implemented internal measures to ensure full alignment with EU GMP Annex 1 standards.

To realize our objective of internal compliance with EU GMP Annex 1, we have committed our efforts to meet the same expectations and standards faced by our industry partners. This has led to a comprehensive re-engineering of various systems and processes, equipping us with a deep understanding of the guidelines and demands associated with contamination control. Our endeavors are guided by a plan centered around four critical pillars: people, communication, process, and continuous improvement.

Effective transformation begins with people, so we have engaged, informed, and encouraged West team members at every stage of our EU GMP Annex 1 journey. Early in the process, we established a centralized multidisciplinary team tasked with owning and overseeing the implementation of our CCS strategy. This team has been essential in providing leadership, direction, and coordinating coherent messaging across the organization.

Additionally, relevant staff members were integrated into a Community of Practice (CoP). This platform facilitates the ongoing sharing of information, learnings, and best practices. It reinforces the belief that West’s goal of enhancing contamination control measures relies on every individual accepting their responsibility to contribute to collective improvement. This philosophy is encapsulated by the empowering mantra ‘See-Do-Say.’

Implementing cultural changes and process improvements in a diverse international business introduces inevitable challenges. To tackle these, we have balanced global thinking with local delivery. Our gap analysis for compliance considered manufacturing controls at both enterprise and local site levels. Subsequently, we developed and approved a master CCS, implemented as an Enterprise Standard Operating Procedure (ESOP). This centralized document serves as a focal point for implementing localized contamination control plans, encompassing all aspects of manufacturing from equipment and environment to processes and personnel.

Beyond implementation, continuous improvement is emphasized. Our knowledge management systems collect data that are compared against internal and external benchmarks, identifying where further iterations and enhancements are possible. This commitment is part of a ‘forever’ lifecycle approach, focusing on the constant evolution of process controls.

In addressing the challenges of EU GMP Annex 1 compliance through these four perspectives—people, communication, process, and continuous improvement—West has developed a coherent, integrated, and impactful approach to enhancing contamination control. More importantly, this approach allows us to offer valuable benefits to our pharmaceutical partners. By understanding the guidelines and aligning with them, our processes, products, and services integrate seamlessly into partners’ compliance efforts. From additional requirements in supporting documentation to strategies for supply and logistics, because we understand what the guidelines require, we can bring clarity and direction in the face of multifaceted, complex demands to limit contamination risk.

Want to learn more? Click to access the other Annex 1 FAQs in our blog series.

• Volume 1 
• Volume 2 
• Volume 3 
• Volume 4 
• Volume 5 
• Volume 6 

To speak with an Annex 1 expert, click here 

If you would like to learn more about meeting EU GMP Annex 1 requirements, click here