Laboratory Control System Operations in a GMP Environment

[b]Develop an understanding of FDA and global regulatory agency requirements for Laboratory Control System (LCS) operations[/b] In [i]Laboratory Control System Operations in a GMP Environment[/i], 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. In this guide, readers learn the fundamental rules for operating a CGMP compliant Laboratory Control System.…