Book Details


Laboratory Control System Operations in a GMP Environment / David M. Bliesner

Publication year: 2020

ISBN: 1119529239

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In Laboratory Control System Operations in a GMP Environment, readers are given the guidance they need to implement a CGMP compliant Laboratory Control System (LCS) that fits within Global Regulatory guidelines. Using the Quality Systems Approach, regulatory agencies like the FDA and the European Medicine Agency have developed a scheme of systems for auditing pharmaceutical manufacturing facilities which includes evaluating the LCS.

Subject: Chemistry, Analytical Chemistry, Quality Assurance, Medical laboratories - Quality control, Laboratories - Management, Pharmacy - Research