Assignment task:
Big Idea 1 - GMPs, Regulations and Quality Systems
(Major Supporting Point a) Good Manufacturing Practices
Question 1: Describe the content of a typical GMP, and identify some regulatory agencies that issues them (e.g. ISO, FDA, etc.).
(Major Supporting Point b) Quality Systems Approach to cGMP Regulations
Question 2: Describe a quality system model focusing on the management responsibilities, resources, manufacturing operations, and evaluation activities, and how they relate to GMPs.