Laboratory control system operations in a GMP environment
- Author
- David M. Bliesner
- Publication Year
- 2020
- Publisher
- John Wiley & Sons
- Language
- English
- Document Type
- Book
- Faculty / Subject Heading
- Medical Science
- Download Book Read book
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.
Keywords: Chemistry / Analytical Chemistry / Quality Assurance / Medical laboratories - Quality control / Laboratories - Management / Pharmacy - Research
