MDM: Quality Assurance 2

Question 1

What is a qualified person?

Answer 1

A Qualified Person (QP) is responsible for assuring the quality of medicines.

QPs are legally responsible for certifying batches of medicinal products before they’re used in clinical trials or available on the market

• Human - directive 75/319/EEC
• Veterinary - directive 81/851/EEC
• Demonstrated competence
• Sufficient appropriate experience(years)
• RSoB, GPhC, RSC or MHRA

Question 2

What does a QP do?

Answer 2

Approves batches for sale or supply

• Batches must be manufactured in compliance
• Is importing out of EU additional tests need to be done to prove compliance
• Approved batch must be entered into the appropriate register

•Compliance with Marketing Authorisation and Manufacturing Authorisation.

• •GMP requirements met.
• •Critical processes validated.
• •QC checks satisfactory.
• •The BMR & BPR review complete.
• •Process deviations recorded & investigated
• •QC checks - from deviations complete.
• •Documentation review & sign-off complete
• •Other aspects (calibration etc) satisfactory

•Legal aspects relating to importation.

• •Problems or product recalls - investigation of organisation and QP
• •Disciplinary actions - temporary suspension, charges of professional misconduct.
• •Final check point between manufacturer and distributor.
• •Eyes and ears of regulatory bodies within the pharmaceutical organisation.

Question 3

What steps are involved in turning an API to a drug for markteing?

Answer 3

1. Drug discovery: Research - discovery of compound by determining pharmacological action
2. Pre Clinical development: Preclinical formulation (simple capsules/ suspensions) for preclinical studies
3. Clinical development: phase I, II, III clinical trials
4. Product to market: Preperation of MAA by regulatory affairs department

Question 4

What preclinical studies are done?

Answer 4

• Formulation
• Preformulation
• Toxicology studies
• biopharmaceutical studies
• stability studies

Question 5

Describe clinical trials

Answer 5

4 Phases:

• Phase I: Healthy patients
• Phase II: Patients
• Phase III: Patients (larger scale)
• Phase IV: Post Marketing surviellence

Question 6

What is marketing Authorisation? Why do we need it and how can we get it?

Answer 6

A document that allows a medicinal product to be marketed

Why: Safety, quality, efficacy

How: common technical dossier (CTD)

Question 7

Who is involved?

Answer 7

Pharmaceutical company:

• -Experts: preclinical, quality, clinical
• Regulatory affairs

The medicine and helathcare product regulatory agency

• assesors and advisiry bodies

Question 8

What is the purpose of the RA department?

Answer 8

• Passes registration doccuments onto regulatory agencies and negoate a marketing and mantaining a authorisation
• Provide technical and strategic advice from the highest level of the compnay
• Advise on legla and scientific restraints/ requirements. Collect, Collate and evaluate data from their develpoment colleagues
• Track ever-changing legislation in regions in which the company wishes to distrubute products
• Takes part in development of the product marketing concept and is usually rquired to approve packaging and advertising

Question 9

Other types of Licences:

Answer 9

• Manufacturer licence for IMPs
• Manufacturer ‘specials’ licence
• Manufacture/Importers licence
• Manufacturer licence exempt advanced therapy products (Hospital exemption licence)
• Manufacturer licence for non-orthodox practitioners

Whole sale dealers

Question 10

Veternary licences

Answer 10

Wholesale dealers, manufacture/import licence, special licence