Conference: Analytical Method Validation and Life Cycle Management - ICH Q14/Q2 (R2)

Objectives

The conference will present and highlight the current developments in the field of method validation and life cycle management. Experts from industry and laboratories will present the current status of the revision and the contents of the guidelines on the one hand, and their own experiences in the establishment and validation of methods and procedures on the other hand.

Background

In March 2022 the European Medicines Agency (EMA) published the ICH guidelines Q2(R2) on validation of analytical procedures and the ICH Q14 on analytical procedure development for public consultation (Step 2b).

The previous harmonised guideline Q2(R1) has been in force in its current form since 2005. At that time, it combined the two guidelines Q2A, which contained analytical methods for required validation parameters, and Q2B, the methodology guideline. In 2018, it was decided to develop a new ICH quality guideline on analytical method development (ICH Q14) and to revise the ICH Q2(R1) guideline on analytical method validation to potentially combine both documents into one document for simplification and clarity. In parallel, the USP also developed the <1220> Analytical Procedure Life Cycle chapter, which was published in October 2021

Together, ICH Q14 and ICH Q2(R2) describe the development and validation activities proposed during the life cycle of an analytical method to assess the quality of medicinal products and medical devices:

• ICH Q14 addresses the scientific basis for the development, change management, and submission requirements of analytical methods for a minimal as well as an extended approach.
• ICH Q2(R2) provides information and specifications for establishing, submitting, and maintaining evidence that an analytical method is fit for purpose (assuring drug product quality).

Target Audience

This conference will be of significant value to

• Laboratory managers, supervisors and analysts
• Quality control managers
• Heads of quality control
• Qualified Persons (QPs)
• Analytical scientists
• Senior laboratory staff
• Responsible authorities

Programme

Key Note on 21 November: The Impact on the Revised Annex 1 for Rapid Microbiological Methods Implementation
Dr Michael Miller

Key Note on 22 November: Preparedness in pandemic vaccine manufacturing and deployment
Prof Dr Isabelle Bekeredjian-Ding

Update on USP <1220> and <1058>
Dr Christopher Burgess

Advantages of the Development of Analytical Procedures by Applying the APLM Principles
Dr Gerd Jilge, Boehringer

Product Life Cycle Concept from the Perspective of the Authorities - Enhanced Approach in Process Validation & Production Routine
Dr Rainer Gnibl, Government of Upper Bavaria

Iterative Validation Approach for Precision: Stage 1 or Stage 2?
Dr Joachim Ermer, Ermer Quality Consulting

The impact of the new ICH Q14 on the Practical Approach to Transfer of Analytical Procedures
Ulla Bondegaard, Novo Nordisk

Case study: Standard and Extended Use of a Validated, Customized Amplex UltraRed Assay for Sensitive Hydrogen Peroxide Detection in Pharmaceutical Water
Dr Alexandra Heussner, Vetter Pharma

Opportunities and Challenges from ICH Q2 (R2) and Q14 for the Analytical Lifecycle
Jean-Francois Dierick, GSK

Analytical Target Profile (ATP) for Large Molecules
Annick Gervais, UCB

Validation for MAA/NDA
Dr Xaver Schratt, GBA Pharma

Implementation of Quality by Design Principles for Analytical Assay Development and Validation
Dr Mohamad Toutounji, Molgenium

HPLC Stability-indicating Procedure Design using Analytical Procedure Lifecycle Approach and AQbD Principles
Dr Amanda Guiraldelli, USP

The use of Design of Experiment to ensure appropriate Understanding throughout a Method's Lifecycle
Patrick Jackson, GSK

Strategies of Overcoming Risks of changing Analytical Methods
Dr Stephan Kirsch, Novartis

Validation of Specific Methods for Inhalation Drug Products
Dr Manfred Fischer, Fischer Consulting