Case Study

Harmonized Qualification Protocols Minimize Compliance Risk And Instrument Downtime

Harmonized Qualification Protocols Minimize Compliance Risk And Instrument Downtime

HARMONIZED QUALIFICATION PROTOCOLS MINIMIZE COMPLIANCE RISK AND INSTRUMENT DOWNTIME Many pharmaceutical companies find it difficult to maintain laboratory compliance against changing standards. In particular, organizations find it hard to interpret United States Pharmacopeia (USP) <1058> and the recently published GAMP Guide “A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems”(second-edition, ISBN 978- 1-936379-48-4). The

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