ICH Q10

Question 1

What is the purpose of ICH Q10

Answer 1

A harmonized pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science

Question 2

What is the objective of ICH Q10

Answer 2

1. Achieve product realisation
2. Establish and maintain a state of control
3. Facilitate continual improvement

Question 3

What is the scope of ICH Q10

Answer 3

1.Applies throughout the product lifecycle
2.Pharmaceutical Development
3.Technology Transfer
4.Commercial Manufacturing
5.Product Discontinuation
6.Applies to the systems supporting the development and manufacture of pharmaceutical drug substances (i.e., API) and drug products, including biotechnology and biological products
7.Application is appropriate and proportionate to lifecycle stage which includes new and existing products.

Question 4

What are the contents of ICH Q10

Answer 4

1. PQS
2. Management responsibilities
3. Continuous management