Quality

Question 1

What is quality?

Answer 1

Ensuring that a product meets specific specifications and is fit for purpose. The right drug, concentration, release and no contaminants or degradation products

Question 2

What is quality assurance?

Answer 2

A wide ranging concept that covers all matters which individually and collectively influence the quality of a product

Question 3

What is quality control?

Answer 3

Part of GMP that is concerned with sampling, specifications, testing and the the organisation, release and documentation procedures that ensure the necessary tests are actually carried out

Question 4

What is ICH?

Answer 4

International committee on the Harmonisation of technical requirements for the registration of pharmaceuticals for Human use

Question 5

What is the role of a QP?

Answer 5

Ensures that each batch is manufactured in compliance with manufacturing authorisation and specific marketing authorisation
Each batch approved must be entered in an appropriate register ASAP after manufacture
Ensure QC is satisfactory

Question 6

What is a marketing authorisation?

Answer 6

A document that allows the marketing of a medicinal product

Question 7

How is a marketing authorisation presented?

Answer 7

In a Common Technical Dosier

Question 8

Examples of other types of licenses

Answer 8

Manufacturing licenses for IMPs
Manufacturing specials license