Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

QP Viva > Law and Admin > Flashcards

Law and Admin Flashcards

1
Q

Name the 6 layers of the law and guidance hierarchy from 1 to 6

A
  1. Law e.g UK acts and Statutory instruments
  2. Regulatory guidance e.g Eudralex, ICH guidance
    3.Consensus standards e.g standards from recognised organisations (ISO, BSI, etc.)
  3. Interpretation e.g. inspection findings
  4. Professional guidance e.g PDA
  5. Company policies and procedures
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

To legally offer a medicinal product for sale relevant government(s) must issue a….?

A

Marketing Authorisation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

How many products can be listed on a marketing authorisation?

A

One, an MA must be obtained for each product

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Marketing authorisations are granted on the basis of evidence of?

A

Safety
Quality
Efficacy

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

What are the four powers of government so with respect to Marketing authorisations?

A

Governments may:
Grant
Refuse
Revoke
Vary marketing authorisations

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Marketing authorisations are known in the EU as?

A

MA marketing authorisations

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Marketing authorisations are known in the UK as?

A

PL Product Licence

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

The four types of marketing authorisations in the US are

A

NDA new drug application
ANDA abbreviated new drug application
NADA New Animal Drug Application
BLA Biologics License Application

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

What is Module one of the Marketing authorisation and why is it unique?

A

It contains regional administrative information and is not part of the Common Technical Document (CTD)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What is included in Module 2 of the Marketing authorisation of the CTD

A

Quality overall summary
Non-Clinical overview
Non-Clinical summary
Clinical overview
Clinical summary

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Quality is Module …. Of the common technical document

A

3

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Module 4 of the CTD is?

A

Non-clinical study reports

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Module 5 of the CTD is

A

Clinical study reports

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Manufacturers of medicinal products must hold a?

A

Manufacturing/Import authorisation (MIA)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Manufacturers must demonstrate what in relation to their MIA?

A

Proper conditions including adherence to GMP

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Manufacturers must name a what on their MIA

A

QP

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

Distributors must hold a what?

A

Wholesale Distribution Authorisation (WDA)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Holders of a WDA must name a?

A

Responsible Person (RP)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

Investigational Medicinal Products require a?

A

CTA clinical trial authorisation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

What does PIC/S stand for?

A

Pharmaceutical inspection cooperation scheme

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

If using an alternative method to a Pharmacopoeial standard what must they often be described in?

A

Regulatory submissions

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

If including an alternative method to a pharmacopoeial standard what must be demonstrated?

A

Equivalence or improvement over the pharmacopoeial standard

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

For what length of time must pharmaceutical preparations comply with the relevant Pharmacopoeia?

A

Throughout shelf life

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

When can secondary reference standards be used for routine analysis

A

When calibrated agains pharmacopoeial standards

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

What does ICH stand for?

A

International Council for Harmonisation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

What are the ICH working groups?

A

Quality
Safety
Efficacy
Multidisciplinary

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

Eudralex volume 4 contains

A

GMP for medicinal products for humans and veterinary use

28
Q

Eudralex volume 9 contains

A

Pharmacovigilance for human and veterinary use

29
Q

Eudralex volume 10 contains

A

Guidelines for clinical trials in humans

30
Q

In the EU human medicines legislation is included in which legislation?

A

Directive 2001/83/EC

31
Q

In the EU Reg. 536/2014 covers what?

A

Clinical trials

32
Q

In the EU Regulation 2019/6 covers what?

A

Veterinary medicines

33
Q

In the EU GMP and inspection for IMPs is covered under

A

Reg. EU 2107/1569

34
Q

Regulation 536/2014 covers

A

EU clinical trials

35
Q

What is the legal duty of the QP stated within Regulation 536/2014

A

To ensure compliance with GMP

36
Q

Regulation 2017/1569 covers GMP for what?

A

IMPs

37
Q

Article 12 of regulation 2017/1569 covers QP responsibilities. What are they?

A

Imported products are to be made in accordance with GMP equivalent to EU GMP for IMPs
Manufacturing is to be compliant with the CTA
Certification is recorded in a register or equivalent

38
Q

What is a type 1A variation

A

Do and tell

39
Q

What is a type 1 b variation

A

Tell, wait and do

40
Q

What is a type 2 variation?

A

Tell and wait for approval

41
Q

What is a type 4 variation

A

Urgent safety restrictions

42
Q

Where would you find the UK legal duties of the QP?

A

SI 2012/1916 Schedule 7 Part 3

43
Q

What are the conditons required to release batches from an MRA country without retesting?

A

A CoA with EU MA test results has to be supplied

You must perform an identity test

You must vary MA to name exporting site as the site of QC testing

QP certification is still required

44
Q

Define a Class I EU recall

A

The defect presents a life threatening or serious risk to health

Communicated via a rapid alert system

45
Q

Define a class II EU recall

A

The defect may cause mistreatment or harm to the patient but it is not life threatening or serious

Communicated via a rapid alert system

46
Q

Define a Class III EU Recall

A

The defect is unlikely to cause harm to the patient and the recall is carried out for other reasons, such as non-compliance with the marketing authorisation or specification

Not communicated via a rapid alert system

47
Q

Which Regulation number is the EU Medical Device Regulation?

A

2017/745

48
Q

Which UK statutory instrument covers Medical device legislation?

A

SI 2002/618

49
Q

State the number of the EU falsified medicines directive

A

2011/62/EU

50
Q

Which schedule of SI 2012/1916 covers Qualified persons

A

7

51
Q

ICH Q1 covers

A

Stability

52
Q

ICH Q2 covers

A

Analytical Validation

53
Q

ICH Q3 covers

A

Impurities

54
Q

ICH Q4 covers

A

Pharmacopoeias

55
Q

ICH Q5 covers

A

Quality of biotech products

56
Q

ICH Q6 covers

A

Specifications

57
Q

ICH Q7 covers

A

GMP for APIs

58
Q

ICH Q8 covers

A

Pharmaceutical Development

59
Q

ICH Q9 covers

A

Quality Risk Management

60
Q

ICH Q10 covers

A

Pharmaceutical Quality System

61
Q

ICH Q11 covers

A

Development and manufacture of APIs

62
Q

ICH Q12 covers

A

Lifecycle management

63
Q

ICH Q13 covers

A

Continuous manufacturing

64
Q

ICH Q14 covers

A

Analytical product development

65
Q

Give the number for the Human Medicines Regulations

A

2012/1916

66
Q

Give the number for the Human Medicines Regulations

A

2012/1916

67
Q

What are the legal duties of the QP according to Annex 16 of Eudralex volume 4

A

Ensure certification is permitted under the terms of the Manufacturer/ Import authorisation, Marketing Authorisation or Clinical Trial authorisation

Ensure any additional requirements of national law have been met

Certified in a register which is available for inspection and up to date

QP Viva (6 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions