Establishing A CGMP Laboratory Audit System: A Practical Guide


The first systematic, hands-on auditing guide for today’s pharmaceutical laboratories In today’s litigious environment, pharmaceutical laboratories are subject to ever stricter operational guidelines as mandated by the FDA, and must be able to establish and demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) regulations. David Bliesner’s Establishing a CGMP Laboratory Audit System:

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About the Author

.Dr Amanda Harvey, Brunel Institute for Cancer Genetics and Pharmacogenomics, Brunel University, Kingston Lane, Middlesex, UK.

Additional information

Weight 567 g
Dimensions 16 × 1.9 × 24.1 cm


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