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Key Concepts and Changes of Annex 1

Posted 14th August 2023 by Wickham Micro Ltd

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Are you prepared for the next chapter in pharmaceutical manufacturing? At Wickham Micro Ltd, we're dedicated to guiding you through this transformative journey. Introducing our exclusive downloadable resource, "Key Concepts and Changes of Annex 1".


Key changes to annex 1 cormica


Stay One Step Ahead

On August 25, 2022! The European Commission has unveiled the long-awaited revised Annex 1 of EU Good Manufacturing Practices (GMP), setting a new course for the production of sterile medicinal products. The countdown is on, as these groundbreaking updates take effect on August 25, 2023. (Please note: a minor exception pertains to the lyophilizers point, section 8.123, which is postponed until August 25, 2024.)

Thriving Amid Change

Since its last revision in 2008, Annex 1 has evolved to match the dynamic pharmaceutical landscape. Our downloadable guide empowers you to seamlessly adapt to these changes, ensuring compliance with the latest Good Manufacturing Practices (GMP) and upholding the highest quality benchmarks.

Key Takeaways:

  1. Quality Risk Management (QRM) Approach: Learn how to implement a holistic manufacturing process that prevents microbial, particulate, and endotoxin/pyrogen contamination in your final product.

  2. Pharmaceutical Quality System (QMS): Explore the role of your PQS in meeting Annex 1 requirements. Discover how to integrate effective risk management systems, ensure expertise in product manufacturing and equipment engineering, and address procedural and equipment failures with suitable corrective and preventive actions.

  3. Holistic Contamination Control Strategy (CCS): Dive into the new CCS approach, covering critical control points, risk management, process validation, preventative maintenance, and more. Ensure your manufacturing facility is a fortress against contamination.

  4. Environmental Monitoring: Learn how to establish an effective environmental monitoring program as part of your CCS. From cleanrooms to utilities, gain insights into maintaining a pristine manufacturing environment.

Your Trusted Partner in Compliance

Feeling uncertain about the new Annex 1 requirements? At Wickham Micro Ltd, we understand the challenges you face. We're here to be your dependable partner on the journey to meeting and exceeding the latest EU GMP Annex 1 standards.

Explore Our Services:

  • Microbiological Environmental Monitoring Solutions: Our expert services ensure your facility meets the stringent standards of Annex 1. From total particle monitoring to viable particle analysis, we’ve got you covered.
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