Pharmaceutical Quality 2

Question 1

What is meant by GMP?

Answer 1

The part of quality assurance aimed at ensuring products are consistently manufactured to the quality appropriate to their intended use

Question 2

What are the two approaches of GMP?

Answer 2

Quality by testing - established approach
- Quality by Design

Question 3

What is the MHRA responsible for?

Answer 3

Regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe

Question 4

What does GMP aim for?

Answer 4

At diminishing the risks inherent in any pharmaceutical production

Question 5

What are the major risks broadly categorised into?

Answer 5

1. Cross contamination
2. Mix ups
3. incorrect or false labelling

Question 6

How do we comply with GMP?

Answer 6

• Several sources of information available
• Pharmacopoeias
• International Conference on Harmonisation (ICH) guidelines
• EudraLex
• Code of Federal Regulation
• The ‘Orange’ guide

Question 7

What is the British Pharmacopoeia ?

Answer 7

• The official, authoritative collection of standards for UK medicinal substances for human and veterinary use
• It is a collection of quality standards for UK medicinal substances

Question 8

What is EudraLex?

Answer 8

• The collection of rules and regulations governing medicinal products in the EU

Question 9

What is the orange guide?

Answer 9

• Provides a single authoritative source of European and UK guidance, information and legislation relating to the manufacture and distribution of human medicines