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Mark Mulvahill, MBA, MSc, discusses the importance of microbial preservation and reference materials in pharmaceuticalmanufacturing and compoundingpharmacies, highlighting their role in contamination control, regulatory compliance, and enhancing microbiological testing reliability.
While focuses on evaluating and establishing supplier reliability for pharmaceuticalmanufacturing companies and compoundingpharmacies, its high-level elements of supplier qualification can also be applied to suppliers of foods and dietary supplement ingredients.
In a 2019 report on drug shortages, the FDA found that 62% of drug shortages occur because of quality issues in manufacturing. Quality issues in pharmaceuticalmanufacturing can arise in many ways. USP engaged its scientific committee and quickly developed standards to support the production of quality hand sanitizers.
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