QMS & QMM

Question 1

What is Quality Control in GMP?

Answer 1

responsible for the testing of incoming raw materials, components, and final products, as well as in-process testing.

Question 2

What is Quality Assurance in GMP?

Answer 2

responsible for evaluating the total arrangements made within a company to ensure that its product and incoming raw materials are of required quality.

Question 3

What are the four stages of Life Cycle Stage goals in the Continual Improvement of Process Performance & Product Quality section of GMP?

Answer 3

1. Pharmaceutical Development
2. Tech Transfer
3. Commercial Manufacturing
4. Product Discontinuation.

Question 4

What is the CAPA System in GMP?

Answer 4

The Corrective Action and Preventive Action (CAPA) System:
a system for implementing
corrective actions resulting from the investigation of complaints, product rejections, non-conformances, recalls, deviations, audits, regulatory inspections and findings,

preventive actions resulting from trends from process performance and product quality monitoring.