Recent Updates Flashcards
Tell me about updates to Annex 1
Introduction of contamination control strategy
New technology- RABS, Isolators, WFI generation
Smoke visualisation requirements as part of room qualifications- recording
Environmental monitoring- personnel and facility under risk assessment.
Movement of materials- Unidirectional flow and separated
Media fill- No allowable growth
Applicability- used in other areas, not just aseptic.
What recent updates are you aware of in the pharmaceutical quality area?
Annex 1- Aug 2023
ICHQ2, Q14
IRP
ICHQ9 update
Windsor framework
Tell me about IRP?
International recognition procedure
Replaces EU decentralised and decision reliance procedure. Targeted approval approach in the UK for reference regulators that have approved (positive CHMP opinion in EU).
Countries on the IRP list;
USA
Japan
EU/EEA
Canada
Australia
Singapore
Switzerland
Tell me about update to ICHQ9
Quality risk management ICH improvements in V2;
Subjectivity in QRM risk assessments and outcomes.
Insufficient management of supply and product availability risks
Lack of understanding of QRM formalities
Lack of clarity about risk-based decision making
Tell me about updates to ICHQ2
Definitions and Terminology: Incorporates biologics terminology
Analytical target profile (ATP) importance during method development and validation.
Risk-based approach to validation, highlighting the importance of understanding and controlling sources of variability.
Transfer of analytical procedures between laboratories and the verification of the procedure’s performance in the receiving laboratory.
Evaluation and management of the analytical procedure throughout its lifecycle.
Presentation of data and the importance of providing a clear and concise validation report.
What changes as part of the Windsor framework?
What are the notification processes?
Current bridging agreement 2022/642- NI supply
Windsor replaces this framework.
UK wide product licence inclusive of Northern Ireland.
From 1st January 2025, packs will no longer conform to EUFMD but have ‘UK only’ as part of their artwork.
Notification;
Self certification
Any regulatory opportunity (not type 1a)
