MDM: QA1 DS

Question 1

1. What is Quality Assurance (QA) and why would it be needed?

Answer 1

Quality assurance is a wide ranging concept that covers all aspects which would influence quality of a medicine. It ensures medicinal products are made to the quality required for their intended use.

Question 2

1. What is a medicinal product or medicine?

Answer 2

A formulation composed of a drug and required excipients. It is intended to treat, cure or prevent a disease

Question 3

What is a batch?

Answer 3

a quantity of goods produced at one time

Question 4

What is a batch doccument?

Answer 4

A doccument which records the details required by the cGMP for batch of product

Question 5

What is a batch number and its purpose?

Answer 5

• A designation printed on a drug label to allow the history of its production to be tracted

Question 6

What is a master batch doccument?

Answer 6

A doccument which defines the manufactuirng method, materials and other procedures

Question 7

What is a master doccument

Answer 7

Manufacturing procedure for each product

Question 8

What is a Master packing doccument

Answer 8

Provides evidence that the right products have been packages in the right container with the right label

Question 9

What are specifications?

Answer 9

A list of tests and their appropriate acceptance criteria with reference to numberical values

Question 10

What are SOPs?

Answer 10

Written instuctions which doccument a routine or repatitive activity for an employee to follow

Question 11

1. What are the GxPs (GMP, GLP & GCP) and to what areas of medicinal development do they apply?

Answer 11

• GCP – quality standard for the performance of a clinical trial on medicinal products involving humans
• GLP – set of principles to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products
• GMP – a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

Question 12

1. What is Quality Control (QC)?

Answer 12

Part of GMP. It ensure that the appropriate and required tests are carried out on medicinal products and that no product/ material is released for sale/ supply unless deemed to be of fit quality

Question 13

1. How are QA, GMP and QC related?

Answer 13

QC is part of GMP which is part of QA

Question 14

1. Who monitors medicines (within the UK)

Answer 14

MHRA

Question 15

1. What is the ICH and what is its purpose?

Answer 15

ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner