MO5 Drug Development

Question 1

Define what drug quality means in terms of medicines

Answer 1

THE FITNESS OF THE MEDICINE FOR ITS INTENDED USE
1. Drug molecule/active ingredient
- safety (no side effects?)
-efficacy (how well does it work?)
2. dosage form
-right strength
-no/little contamination
-not degraded
3. Packaging
- in the right container that is properly sealed, protected and labelled

Question 2

Define quality assurance

Answer 2

COVERS ALL MATTER THAT INDIVIDUALLY OR COLLECTIVELY INFLUENCE THE QUALITY OF A MEDICINE. DESIGN AND MANUFACTURING.
1. Good laboratory practice GLP
2. Good Clinical Practice GCP
3 Good manufacturing practice GMP incl. quality control QC

Question 3

What is the drug discovery process ‘pipeline’ and what are the steps involved?

Answer 3

• Stage 1- discovery (bench)
• stage 2- non/pre-clinical (animals)
• stage 3- clinical (humans)
• stage 4- post-approval
• manufacturing (pharmaceutical company) begins during clinical and during post approval stages

Question 4

What are the differences between drug discovery and drug manufacture?

Question 5

What is GMP

Answer 5

GMP describes proven systems and procedures for the production and distribution of quality medicines. Encompasses
- both manufacture of raw materials and products
- DOCUMENTATION
- QUALITY CONTROL
- personnel
- premises and equipment
- production
- contract manufacturing and analysis
- complaints and product recall
- self inspection

Question 6

Describe stage 1 of the drug pipeline

Answer 6

DISCOVERY- lead compound undergoes biological testing, analogues are created of which structure activity relationships are analysed to end up with potential drug candidates. Attempting to optimise/consider physical properties of molecule and think about drug delivery.

Question 7

Describe stage 2 of the drug discovery pipeline

Answer 7

NON-CLINICAL- safety testing on animals to see if the drug candidates work or if they are potentially harmful to a living organism. Good laboratory practice.

Question 8

Describe stage 3 of the drug discovery pipeline

Answer 8

CLINICAL- studies in humans to assess efficacy and in early phases still testing for toxicity. Occurs after the guidelines of GLP have been met. Good clinical practice.

Question 9

What is quality control

Answer 9

Part of GMP, testing and checking of raw materials, some intermediates and final product before release. Conforms to the specifications either in a medical dossier or pharmacopoeia.

Question 10

Why is documentation an essential part of GMP (and therefore quality assurance)?

Answer 10

-ensures there are specifications to follow for all materials and methods of manufacture and control.
- ensures all personnel know what to do and how to do it
- ensure that authorised people have the necessary info for release
- provide audit trail, auditors can check the guidelines are being followed

Question 11

What are the types of GMP Documentation

Answer 11

1. Standard operating procedure (how to use a piece of equipment
2. Manufacturing instructions (how to make a specific medicine)
3. Records (made for auditors to show medicine is of high quality)
4. Specifications (standards and acceptable limits for quality of raw materials, formulations and finished products. Aim to ensure safety and efficacy of final product)`

Question 12

What are the critical quality attributes for API and excipients?

Answer 12

• identity (chemical and physical description… is it the right thing)
• purity (active ingredient is of sufficient purity)
• homogeneity (impurity identity and quantity)
• for a drug product, tablet dissolution, stability, container closure system etc.