Sterile Products : Secure Your Compliance with GMP Annex 1

📃 The revised Annex 1 of the EU Good Manufacturing Practices, applicable since 2024, represents a major milestone for sterile products.

Beyond reinforced regulatory expectations, this revision calls for a broader transformation : a comprehensive, lifecycle-based and risk-driven approach to contamination control.

Critical challenges for injectable products

🎯 In this new regulatory environment, manufacturers must be able to demonstrate robust control of critical risks, including :

• Particulate contamination – USP <788> / Ph. Eur. 2.9.19
• Microbiological contamination
• Container-content interactions, including extractables & leachables
• Container closure integrity before use – USP <1207>
• Container closure integrity after representative simulated use – USP <382>
• Control of aseptic processes and manufacturing environments

In this context, partnering with an expert analytical laboratory becomes a key lever to identify these risks and safeguard your products throughout their lifecycle.

CEBIPHAR’s expertise in sterile injectables

CEBIPHAR has supported pharmaceutical manufacturers through an integrated analytical approach combining scientific expertise, regulatory understanding, and practical experience with complex sterile products :

• Subvisible and visible particle analysis
• Extractables & leachables (E&L) studies
• Container closure integrity testing (CCIT)

🤝 What sets CEBIPHAR apart

• Compliance : command of international regulatory requirements
• Agility : adaptability to complex cases and operational responsiveness
• Science : in-depth scientific interpretation of analytical data
• Trust : reliability of results and trusted partnership

📩 Let’s talk about your analytical and regulatory challenges !