Key Concepts and Changes of GMP EU Annex 1

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Published:

14/08/2023

Author:

Wickham Micro Ltd

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Are you prepared for the future of pharmaceutical manufacturing? The landscape is changing, and we’re here to guide you through every step. Introducing our comprehensive downloadable Technical resource, “Key Concepts and Changes of Annex 1,” designed exclusively for pharmaceutical manufacturers like you.

 

Key changes to annex 1 cormica

 

Stay Ahead of the Curve

 

On August 25, 2022, the European Commission unveiled the highly anticipated revised Annex 1 of EU Good Manufacturing Practices (GMP), reshaping the way sterile medicinal products are produced. The countdown to the new standards is on, as these updates come into effect on August 25, 2023, with a minor exception (lyophilizers point, section 8.123) postponed until August 25, 2024.

 

Adapt and Thrive

 

The pharmaceutical landscape has evolved since the last Annex 1 update in 2008. Our downloadable PDF will equip you with the knowledge to navigate these changes seamlessly, ensuring compliance with the latest Good Manufacturing Practices (cGMP) and maintaining the highest quality standards.

 

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 Partner in Compliance

 

Are the new Annex 1 requirements causing uncertainty? Don’t face these changes alone. Wickham Micro Ltd & Cormica are your trusted ally, dedicated to your success in meeting 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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