QP01 Law

Question 1

GMP Annexes 1 - 5

Answer 1

1 - Manufacture of Sterile Products
2 - Manufacture of Biologics
3 - Radiopharmaceuticals 
4 - Veterinary products (excluding immunologicals)
5 - Veterinary immunological products

Question 2

GMP Annexes 6 - 10

Answer 2

6 - Medicinal Gases
7 - Herbal Medicines
8 - Testing of Starting and Packaging Materials
9 - LCO
10 - PMDI

Question 3

GMP Annexes 11 - 21

Answer 3

11 - Computerized Systems
12 - Use of Ionizing Radiation
13 - IMP
14 - Medicinal products derived from human blood or plasma
15 - Validation
16 - Batch Certification
17 - Parametric Release
18 - X
19 - Reference and Retain Samples
20 - QRM
21 - Importation (DRAFT)

Question 4

Human parent directives, GMP and GDP requirements

Answer 4

Parent Directive
EU - 2001/83/EC
UK - 2012/1916

GMP Regs
EU - 2017/1572
UK - 2012/1916

GMP Guidelines
EU - Eudralex Vol. 4 Part 1
UK - Follows EU

GDP
EU - 2013/C343/01
UK - Follows EU

Question 5

Vet parent directives, GMP and GDP requirements

Answer 5

Parent Directive
EU - 2019/6
UK - 2013/2033

GMP Regs
EU - 91/412/EEC
UK - 2013/2033

GMP Guidelines
EU - Eudralex Vol. 4 Part 1
UK - Follows EU

GDP
Follow human - 2013/C343/01

Question 6

ATMP parent directives, GMP and GDP requirements

Answer 6

Parent Directives
EU - 2001/83/EC
UK - 2012/1916 amended by 2019/775

GMP Regs
EU - 1394/2007 and for IMP - 2017/1569
UK - 2012/1916

GMP guidelines
EU - Eudralex Vol 4 part 4
UK - follow EU

GDP
None but risk based approach

Question 7

IMP parent directives, GMP and GDP requirements

Answer 7

Parent directives
EU - 536/2014
UK - 2004/1031

GMP Regs
EU - 2017/1569
UK - 2004/1031

GMP guidelines
EU - Eudralex Vol. 4 part 1
UK - follow EU

GDP
None - but a risk based approach is expected

Question 8

API parent directives, GMP and GDP requirements

Answer 8

Parent directives
EU - 2001/83/EC
UK - 2012/1916

GMP Regs
EU - 1252/2014
UK - 2012/1916 amended by 2019/775

GMP guidelines
EU - Eudralex Vol. 4 part 2
UK - Follow EU

GDP
EU - 2015/C95/01
UK - follow EU

Question 9

Excipient parent directives, GMP and GDP requirements

Answer 9

Parent directive
EU - 2001/83/EC
UK - 2012/1916 amended by 2019/775

GMP Regs
Risk assessment and apply appropriate GMP

GMP guidelines
None - but NSF/IPEC/ANSI guide 363-2019