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Tag: universal stability protocol

Harmonizing Stability Protocols for Global Markets: A Regulatory and Operational Roadmap

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Harmonizing Stability Protocols for Global Markets: A Regulatory and Operational Roadmap Harmonizing Stability Protocols for Global Markets: A Regulatory and Operational Roadmap Introduction In an increasingly globalized pharmaceutical landscape, manufacturers routinely seek to market products across multiple regulatory jurisdictions—each with its own set of stability testing requirements. While the ICH Q1 series of guidelines serves…

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Harmonizing Stability Protocols for Global Markets, Regional Stability Guidelines

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  • Include Microbial Limits Testing in Stability Studies Where Applicable

    Understanding the Tip: What is microbial limits testing in stability studies: Microbial limits testing evaluates the total microbial count and the presence of specific objectionable… Read more

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