MDM: Quality 2 DS

Question 1

Briefly describe the purpose of a Qualified Person (QP) within the context of an organisation which manufactures and markets medicines.

Answer 1

Assess quality of medicines and approves or rejects batches of medicines for sale/supply/clinical trials depending on compliance

Question 2

Briefly explain some of the roles required of a QP the process of them carrying out the purpose outlined above.

Answer 2

Assesses compliance with QA

Asses compliance with GMP

Approves/ rejects batches

Ensures critical process validated

Records and investigates deviations from procedures

Investigates product recalls/ problems

Question 3

As the term ‘Qualified Person’ is defined in law identify the four bodies who can certify whether a person is appropriately trained to hold such a title.

Answer 3

RSoB, GPhC, RSC or MHRA

Question 4

Briefly explain when each of the following types of marketing authorisation application procedures would be used:

1. Centralised procedure.
2. National procedure.
3. Mutual recognition procedure.
4. Decentralised procedure.

Answer 4

1. Centeralised procedure - used to market certain medicines throughout EU
2. National procedure - if want to market a medince in UK only
3. Mutual recognition procedure - If already have national licence in one or more EU countries and want to market it in another
4. Decentralised proceudre - if want to market it in UK and other named EU countries

Question 5

Explain what the following licence types allows the holder to do:

1. Manufacture / importer licence.
2. Manufacturer ‘specials’ licence.
3. Manufacturer licence for investigational medicinal products.
4. Manufacturer licence exempt advanced therapy products (Hospital exemption licence).
5. Manufacturer licence for non-orthodox practitioners.

Answer 5

Question 6

Explain the flowing abbreviations used within the development and production of medicinal products and state to what aspects of the process they apply:

1. GMP.
2. GLP.
3. GCP.
4. GPvP.
5. GDP.

Answer 6

1. Good manufacturing practice (GMP) is the minimum standard that a medicines manufacturer must meet in their production processes. Products must:

• be of consistent high quality
• be appropriate to their intended use
• meet the requirements of the marketing authorisation (MA) or product specification

1. Good distribution practice (GDP) requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the MA or product specification.
2. Good Pharmacovigilance Practice (GPvP) is the minimum standard for monitoring the safety of medicines on sale to the public in the EU
3. GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical non-clinical safety tests
4. Good Clinical Practice (GCP) is the international ethical, scientific and practical standard to which all clinical research is conducted