Roles & Professional Duties Of A QP

Question 1

Describe the structure of the MHRA?

Answer 1

Part of the department for Health and Social Care

3 Arms consisting of:-
Science Research and Innovation, Healthcare Quality and Access, Safety and Surveillance

Main interaction with MHRA is via inspections - this is split in to two teams:-
Team 1 - GCP, GLP and GPvP
Team 2 - GDP and GMP

Question 2

What do EDQM do?

Answer 2

European Directorate for the Quality of Medicines

Grant CEP’s, Establish EP, Provide guidance and standards,

Question 3

What are the 21 Routine Duties of a QP?

Answer 3

Investigations
TSE
Sites
Quality Control
Activities
Validation
API’s
Inspection (Self)
Distribution
Excipients
Record
Supply Chain Maps
Marketing (Post)
Audits
GMP
Import of API
Changes
Complaints
Agreements
Tamper (Safety Features)
Source / Specs Starting Mats

Question 4

What’s the difference between a Commercial QP Declaration vs an IMP QP Declaration?

Answer 4

Commercial:- For API only, Issues by MAH and signed by QP. Required for all marketed products

IMP - Confirm IMP finished product quality compliance. Included as part of CTA. Required for all IMPs imported into EU / UK

Question 5

What is different for the certification of Biological Products?

Answer 5

QP will certify - batch will be quarantined

C of A, Test Methods, Filling Method, C of C will be sent to NIBSC ( National Institute for Biological Standards and Control)

NIBSC will produce OCBR (Official Control Authority Batch Release) certificate

MHRA will receive this from NIBSC and will give there release or if no response within 2 weeks batch can be released

Question 6

What guidelines do we have for impurities?

Answer 6

ICH Q3 and M7

Vol 4 Part III Health Based Exposure Linits

Eudralex Vol 3

Question 7

What can you NOT delegate as a QP?

Answer 7

Annex 16 - 1.6

Certification is permitted under the MIA
Any additional duties and requirements of National Legislation are complied with
Certification in a register or equivalent

Question 8

What are the 4 post approval changes to MAs?

Answer 8

Type 1A - Do and Tell
Type 1B Tell wait and Do
Type 2 Tell and Wait

Urgent Safety Restriction

Question 9

What are the legal Duties of a commercial QP and where can you find them?

Answer 9

Medicine is manufactured and assembled in line with its MA, GMP and National Law

Medicine imported from 3rd Countries require full qualitative and quantitative analysis unless a MRA is in place

Safety Features affixed for EU

Certification in a register or equivalent