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The revised GMP Annex 1 guidelines emphasize quality risk management, enhanced environmental monitoring, and data integrity, aiming to minimize contamination and ensure patient safety.
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Review the implementation of a holistic CCS and increased emphasis on Container Closure Integrity (CCI). Discover four key considerations for assessing component readiness: product, process, protection, and proof.
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Navigate the 2023 EU GMP Annex 1 revisions, which emphasize contamination control strategy, RABS/isolators, and personnel training for sterile product manufacturing compliance.
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EU GMP Annex 1's impact is felt throughout the entire supply chain. To meet it, a CCS should focus on people, communication, process, and continuous improvement for effective and sustainable compliance.
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EU GMP Annex 1 has demanded a complex and fundamental re-engineering of approaches to contamination control, in terms of operations, processes, and systems as well as mindset and behaviors.
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A CCS enables a holistic approach to risk management, proactively identifying vulnerabilities and ensuring compliance, emphasizing an integrated method to mitigate microbial, particulate, and chemical risks.
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By integrating Annex 1 into contamination control efforts, companies can strengthen their risk mitigation strategies while ensuring regulatory alignment. USP <382> also plays a critical role in ensuring the quality and safety of elastomeric components. Join us to gain valuable insights into best practices and proactive approaches for building a robust and future-ready contamination control strategy. For more information, watch the on-demand webinar.
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