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Navigating Pharmaceutical Quality Assurance: A Comprehensive Guide P5

๐…๐จ๐œ๐ฎ๐ฌ๐ข๐ง๐  ๐จ๐ง ๐ƒ๐š๐ญ๐š ๐ˆ๐ง๐ญ๐ž๐ ๐ซ๐ข๐ญ๐ฒ: Numerous recent Health Authority enforcement actions, such as Warning Letters, Import Alerts, Product Detentions and suspension or revocation of Marketing Authorizations, have focused attention on data integrity

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Microbial Contamination

FDA Trends and Remediation Efforts | Author: Kim Lim Introduction There are several different cases of microbial contamination in manufacturing settings cited by FDA warning letters in 2022.ย  These cases cross several different manufacturers, from medical devices to over-the-counter (OTC) to compounding pharmacies to positron emission tomography (PET) for parenteral administration.ย  The cause of the

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