ECA's Analytical QC Group has developed a new Guideline on Analytical Procedure Lifecycle Management (APLM).
The purpose of this ECA AQCG guideline is to provide;
1. An overview and framework for a lifecycle approach to the qualification of analytical procedures as part of a lifecycle approach which is consistent with the principles of the FDA process validation guideline and regulatory expectations.
2. Descriptions and recommendations regarding the staged activities in the lifecycle.
3. Input for the forthcoming revision of ICH Q2(R1), the new Q14 and support of the on-going development of USP General Chapter <1220> on Analytical Procedure Lifecycle.
4. Guidance on the application of the lifecycle approach for existing methods and procedures.
5. A focus for debate regarding the practical implementation of APLM within the industry.
This guideline is intended to apply to chemical methods of analysis for both univariate methods such as HPLC, UV spectrophotometric assays for example and multivariate methods for identification of materials using FTIR, FTNIR and Raman spectroscopies for example. Univariate is a term commonly used in statistics to describe a type of data which consists of observations on only a single characteristic or attribute whereas multivariate encompasses the simultaneous observation and analysis of more than one outcome variable
These principles also apply to biopharmaceutical assay methods. Biological and microbiological methods are not explicitly covered by this guideline.
A full day workshop session and launch of this new 80 page guideline will take place during the PharmaLab Congress 2018 in Dusseldorf.
Dr Christopher Burgess
Chairman of the ECA Analytical Quality Control Group