Laboratory control system operations in a GMP environment
- المؤلف
- David M. Bliesner
- سنة النشر
- 2020
- الناشر
- John Wiley & Sons
- لغة الملف
- انكليزي
- نوع الملف
- Book
- تصنيف الكتاب
- Medical Science
- تحميل الكتاب قراءة الكتاب
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