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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
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2
Q

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

A

Marketing Authorisation

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3
Q

How many products can be listed on a marketing authorisation?

A

One, an MA must be obtained for each product

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4
Q

Marketing authorisations are granted on the basis of evidence of?

A

Safety
Quality
Efficacy

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5
Q

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

A

Governments may:
Grant
Refuse
Revoke
Vary marketing authorisations

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6
Q

Marketing authorisations are known in the EU as?

A

MA marketing authorisations

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7
Q

Marketing authorisations are known in the UK as?

A

PL Product Licence

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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

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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)

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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

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11
Q

Quality is Module …. Of the common technical document

A

3

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12
Q

Module 4 of the CTD is?

A

Non-clinical study reports

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13
Q

Module 5 of the CTD is

A

Clinical study reports

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14
Q

Manufacturers of medicinal products must hold a?

A

Manufacturing/Import authorisation (MIA)

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15
Q

Manufacturers must demonstrate what in relation to their MIA?

A

Proper conditions including adherence to GMP

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16
Q

Manufacturers must name a what on their MIA

A

QP

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17
Q

Distributors must hold a what?

A

Wholesale Distribution Authorisation (WDA)

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18
Q

Holders of a WDA must name a?

A

Responsible Person (RP)

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19
Q

Investigational Medicinal Products require a?

A

CTA clinical trial authorisation

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20
Q

What does PIC/S stand for?

A

Pharmaceutical inspection cooperation scheme

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21
Q

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

A

Regulatory submissions

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22
Q

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

A

Equivalence or improvement over the pharmacopoeial standard

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23
Q

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

A

Throughout shelf life

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24
Q

When can secondary reference standards be used for routine analysis

A

When calibrated agains pharmacopoeial standards

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25
What does ICH stand for?
International Council for Harmonisation
26
What are the ICH working groups?
Quality Safety Efficacy Multidisciplinary
27
Eudralex volume 4 contains
GMP for medicinal products for humans and veterinary use
28
Eudralex volume 9 contains
Pharmacovigilance for human and veterinary use
29
Eudralex volume 10 contains
Guidelines for clinical trials in humans
30
In the EU human medicines legislation is included in which legislation?
Directive 2001/83/EC
31
In the EU Reg. 536/2014 covers what?
Clinical trials
32
In the EU Regulation 2019/6 covers what?
Veterinary medicines
33
In the EU GMP and inspection for IMPs is covered under
Reg. EU 2107/1569
34
Regulation 536/2014 covers
EU clinical trials
35
What is the legal duty of the QP stated within Regulation 536/2014
To ensure compliance with GMP
36
Regulation 2017/1569 covers GMP for what?
IMPs
37
Article 12 of regulation 2017/1569 covers QP responsibilities. What are they?
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
What is a type 1A variation
Do and tell
39
What is a type 1 b variation
Tell, wait and do
40
What is a type 2 variation?
Tell and wait for approval
41
What is a type 4 variation
Urgent safety restrictions
42
Where would you find the UK legal duties of the QP?
SI 2012/1916 Schedule 7 Part 3
43
What are the conditons required to release batches from an MRA country without retesting?
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
Define a Class I EU recall
The defect presents a life threatening or serious risk to health Communicated via a rapid alert system
45
Define a class II EU recall
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
Define a Class III EU Recall
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
Which Regulation number is the EU Medical Device Regulation?
2017/745
48
Which UK statutory instrument covers Medical device legislation?
SI 2002/618
49
State the number of the EU falsified medicines directive
2011/62/EU
50
Which schedule of SI 2012/1916 covers Qualified persons
7
51
ICH Q1 covers
Stability
52
ICH Q2 covers
Analytical Validation
53
ICH Q3 covers
Impurities
54
ICH Q4 covers
Pharmacopoeias
55
ICH Q5 covers
Quality of biotech products
56
ICH Q6 covers
Specifications
57
ICH Q7 covers
GMP for APIs
58
ICH Q8 covers
Pharmaceutical Development
59
ICH Q9 covers
Quality Risk Management
60
ICH Q10 covers
Pharmaceutical Quality System
61
ICH Q11 covers
Development and manufacture of APIs
62
ICH Q12 covers
Lifecycle management
63
ICH Q13 covers
Continuous manufacturing
64
ICH Q14 covers
Analytical product development
65
Give the number for the Human Medicines Regulations
2012/1916
66
Give the number for the Human Medicines Regulations
2012/1916
67
What are the legal duties of the QP according to Annex 16 of Eudralex volume 4
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 (8 decks)

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