Laboratory control system operations in a GMP environment
المؤلف
David M. Bliesner
سنة النشر
2020
الناشر
John Wiley & Sons
لغة الملف
انكليزي
نوع الوثيقة
Book
الموضوع الرئيسي / الكلية
Medical Science
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.
الكلمات المفتاحية: Chemistry / Analytical Chemistry / Quality Assurance / Medical laboratories - Quality control / Laboratories - Management / Pharmacy - Research
