Law & Administration Flashcards
What are the 9 Chapters of EU GMP?
1 PQS
2 Personnel
3 Premises and Equipment
4 Documentation
5 Production
6 QC
7 Outsourced Activities
8 Complaints / Recall
9 Self Inspection
What Are the ICH Guidelines?
Q1 Stability
Q2 Analytical MV
Q3 Impurities
Q4 Pharmacopeia
Q5 Biotech
Q6 Specifications
Q7 API
Q8 Pharm Dev
Q9 QRM
Q10 PQS
Q11 Development
Q12 Lifecycle Management
Q13 Continuous Manufacture
Q14 Analytical Procedure
M6/8 CTD eCTD
M7 Mutagenic Substances
What is the SI for Vetenary?
SI 2013 / 1033
Legal Duties of a QP can be found in?
SI 2021 1916 - schedule 7
SI 2004 1032 - section 13 / 43
2001 83 EC article 51
2017 1569 article 12
SI 2013 2033
2001 82 EC
What guidelines relate to ATMP’s?
Part 4 Eudralex Vol 4
What is an RPi?
Responsible Person for Importation
Brought in post Brexit to ensure QP certification has taken place for products imported from EU / EEA
What are the SI for Commercial and IMPs?
SI 2012 1916
SI 2004 1031
What countries are on the list of approved countries post Brexit for not requiring import testing?
EU / EEA
Australia
Israel
Japan
Switzerland
USA
Canada
New Zealand
What is a parallel import?
When a medicine is legally moved from one member state to another without permission of the company that own the Intellectual Property
It allows the product to be marketed in another member state provided the products have ‘NO THERAPEUTIC DIFFERENCE’
Usually done for cost reasons
What are the Recall Classifications?
National Patient Safety Alert (Class 1)
Class 2
Class 3
Caution in Use (Class 4)
What is regulation 174?
Used during pandemic to authorise vaccines for emergency use based on safety, quality and efficacy data prior to authorisation of MA
Talk through the Northern Ireland Protocol?
EU proposal for NI - allow uninterrupted flow of medicines to patients
Medicines made in GB can be exported to NI provided that EU law is complied with, legal prohibition of re-sale, FMD safety provisions applied.
What is NIMAR?
Northern Ireland MHRA Authorised Route
New Route for supply of medicines to NI
POMs only, GB licence and only when there is a clinical need that can’t be met.
What are the updates to ICH Q9 in Feb 2023?
Section 5 Risk Management Methodology
- Formality in RA (Uncertainty, Importance, Complexity)
- Risked based decision making
Managing and minimising subjectivity
New info added for QRM of supply chains
- Supplier oversight and relationships
- Facilities and Equipment
- Manufacturing Processes Variation
Give details of the update to SI 2012 1916 post Brexit?
Amendment 775
- update to refer to UK MAs
- List of approved countries
- BP instead of EP
- Inclusion of EU / EEA as approved country
- Role of the RPi
- Removal of some references to 2001 83 EC
What is the sunset clause?
You have 3 years after the MA approval to market a product
What are the different types of MA in EU?
Centralised- single MA valid in all markets
De-Centralised- application to all member states at the same time
National- Products restricted to one member state
Mutual Recognition- MA in one state but mutually recognised by all
Latest Regulatory Updates?
Annex 1
Annex 21
SI 2012/1916
SI 2004/1031
ICH Q9
International Recognition Procedure
Talk through Annex 1 Updates
Annex 1 finalised 2022 but not fully implemented until 2024
- significant increase in content
- Introduction of QRM principles
- Discussion on new technologies - RABs, Isolators, nano-filtration
- Contamination Control Strategy
- Clean rooms - monitor at rest and smoke work
- PST - 0cfu and how to perform PST when product is frozen or lyophilised
- Personnel training expectations
What is the International Recognition Procedure?
From 1st Jan 2024 IRP can be used for MA applications- the MHRA will take in to account the expertise and decision-making of trusted regulatory partners for the benefit of UK patients.
These include:-
Australia
Canada
Switzerland
Singapore
Japan
US
EU/EEA
Herbal Medicines are Excluded
When is the Windsor Framework to be implemented by?
01 Jan 2025 -
Bridging Mechanism in place to allow companies to supply medicines to NI that are subject to EU Centrally Authorised Procedure for up to 6 months
‘UK Only’ can be applied via label up until 30 June 2025 - after it must be printed directly on to packaging
What is the Windsor Framework?
Announced Feb 2023
- UK rather than EU legislation will apply in NI
- MHRA will approve medicines for the whole UK market including NI
- Falsified Medicines Directive Provisions such as Serialisation will no longer apply.
- Packs exported to NI will be labelled ’for UK only’
What are the latest updates to ICH Q2
Main updates from Dec 2023 are as follows:-
The addition of an Annex 2 which illustrates how performance characteristics of various different analytical techniques could be validated.
- Quantitative Separation Techniques (HPLC , GC)
- Elemental Impurities
- Dissolution
- Binding Assay
- Quantitative PCR
- Particle Size
- NIR Methods
- LC/MS
What are the latest updates to ICH Q14?
Dec 2023
Application of Quality By Design (ICH Q8) and Quality Risk Management Principles (ICH Q9) to development lifecycle of analytical procedures.
- Specifies minimum and enhanced approach to analytical procedure development.
- Describes the considerations for multivariate analytical procedures and for real time release testing.
- provides principles to support change management of Analytical procedures
- Submissions consideration’s analytical procedure development and lifecycle information for CTD.
Had 3 Annexes -
Analytical Procedure Lifecycle
Validation Strategies for method operational design regions MODRs
Examples of multivariate model lifecycle components
What is the amendment to veterinary regulation 2013/2033?
SI 2024 / 567
What are the new duties of a QP relating to Veterinary Amendment?
If veterinary medicine is recalled and physically recovered the QP must asses the product
a) has been stored in accordance with the summary of product characteristics
b) the product is not counterfeit
If not stored correctly or it is counterfeit then product can’t be re-sold
What are CERS countries?
UK law allows the VMD to recognise batch testing conducted in these countries for veterinary medicines as equivalent standards
