How should modern analytical development be conducted?

Recommendation

12-14 December 2023

Stability by Design - Live Online Training
- Stability Testing in Product Design and Method Development- Focus mainly on small-molecule APIs and drug products

In 2017, the board of the ECA Foundation's Analytical Quality Control Group (AQCG) has decided to strengthen the lifecycle approach for analytical procedures. Therefore, the Group developed a new guideline on "Analytical Procedure Lifecycle Management".

The draft for this guideline was discussed with the participants of the Analytical Procedure Lifecycle Management Conference on 23/24 November, 2017 in Vienna. The conference objective was to collect proposals and suggestions for the final version of this guideline. Meanwhile, the ECA QC Group has considered the received suggestions and implemented them as far as possible.

The AQCG is currently in the process of finalizing the final Version 1.0.

In this comprehensive Analytical Procedure Lifecycle Management guideline, the following points are presented and discussed:

• Key References
• Quality involvement/Responsibilities
• Rationale for this Guideline
• Principles of Analytical Procedure Lifecycle Management (APLM)
• Prerequisites for the APLM
• Guidance recommendations for the 3 stages of the APLM
• Stage 1: Procedure Design and Development
• Procedure development and gaining understanding
• Establishing an Analytical Control Strategy
• Establishing a Replication Strategy 
• Stage 2: Procedure Performance Qualification
• Stage 3: Procedure Performance Verification
• Technical Glossary

The final Version 1.0 of this guideline will be presented at the ECA APLM Workshop on 20 November 2018 as part of the PharmaLab Congress 2018 in Düsseldorf/Neuss in Germany. Each participant will receive a copy of this important new APLM document, and thereby an important tool for implementing a lifecycle approach to analytical development in one's own company.