Since Annex 1 came into effect in 2023, pharmaceutical manufacturers are under more pressure than ever to redesign their sterile operations with a holistic, contamination-prevention mindset. But implementing a robust, facility-wide contamination control strategy can be daunting, especially when resources, instrumentation, or expertise are limited. Whether you're navigating internal manufacturing or managing CDMO oversight, achieving Annex 1 compliance is now a critical, resource-intensive endeavour.

Through our network of ISO 9001-certified laboratories and GMP-compliant microbiology services, Eurofins BPT provides a structured, science-led approach to Annex 1 readiness. The key concepts of this approach are:

• Quality risk management (QRM)
• Contamination control strategy (CCS)
• Continuous monitoring approach
• Pharmaceutical quality system

Our internal microbiology technical councils have defined best practices and shared harmonised approaches to support the specific validation and quality control requirements of new Annex 1 in the following areas:

• Environmental monitoring
• Cleaning & disinfection validation
• Disinfectant validation studies & quality controls
• Water & steam systems – qualification & monitoring
• Gases & compressed air
• Aseptic processing validation
• Sterilisation and depyrogenation
• Raw materials & packaging
• Single-use systems
• Quality control

Where a compliance gap is identified, our Healthcare Assurance team can provide expert-led gap analyses and audits, helping you understand the work required to meet new expectations. For those managing outsourced production, we also perform third-party CDMO audits to ensure end-to-end compliance.

For manufacturers without teams or tools in-house, Eurofins PSS Insourcing Solutions can provide fully trained microbiology professionals on-site if needed, meaning you can execute your strategy without recruitment delays or capital expense.

Whether you’re designing a new facility, validating existing systems, or urgently responding to regulatory expectations, the Eurofins BPT team of scientists, technical consultants, and auditors are equipped to ensure your approach is compliant, controlled, and complete.