samedan logo
 
 
 
spacer
home > ebr > summer 2020 > risk management for analytical method development
PUBLICATIONS
European Biopharmaceutical Review

Risk Management for Analytical Method Development

Process development and validation, batch release tests, routine analysis, product characterisation, and stability studies have their foundations in reliable analytical methods. This justifies the existence of a dedicated ICH guideline – the analytical methods validation guideline – ICH Q2 – introduced 25 years ago (1). A significant number of developments have occurred in regulatory science over the past two decades. As such, ICH Q14 will address, in addition to validation (cf. Q2), several new aspects of the analytical procedure’s development that will ensure better performance over lifecycle. ICH Q14 (draft planned for 2020) is expected to expand Q2 and address current regulatory gaps related with explicit use of risk-based considerations and formalised change-management procedures. A similar situation existed for product and process development for which a linkage was established with the development of the ICH Q8, Q9, Q10, and the most recent guideline, Q12, on lifecycle and postapproval change management, LCM and PACM respectively. The concepts of quality by design (QbD), established by Q8, can be extrapolated and adapted for analytical method development – known as analytical quality by design (AQbD). ICH Q14 is expected to integrate the above aspects on risk-based QbD, LCM and PACM.

The current approach to analytical method development does not follow a systematic approach – the work is defined according to the results that are sequentially obtained, which usually leads to non-optimised methods (3). The AQbD process is very similar to the one described in the ICH Q8 (within the pharmaceutical development context), in the sense that it is a structured approach with a predefined goal and a strong focus on method understanding using risk-based and data-driven approaches (4-5). Although it may be necessary to invest more time and effort in the beginning of the development, it is compensated in the long run with less work and shorter timelines. Figure 1 presents the steps involved in the development of an analytical method via the AQbD approach. With this framework, not only is the method’s performance optimised, but the risk-based and data-driven methodologies provide a strong knowledge base to be applied for the lifecycle management. This supports an efficient change-management system and continued method performance and verification activities.



Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

 You must be a member of the site to make a comment.
spacer
Madalena R Testas is currently a Senior MSAT Engineer at 4Tune Engineering, responsible for managing and executing projects in both the pharma and biopharma areas. She has worked in several industrial projects with clients in Europe, the US, and South America, involving QbD, quality risk management (QRM), process analytical technologies (PAT), continued process verification, and data science. Madalena holds a BioEngineering degree from the Technical University of Lisbon, Portugal, and a MSc from a top pharmaceutical and equipment supplier in a resource optimisation project using PAT.

Daniela B Santos is the Head of the Business Marketing and Sales department at 4Tune Engineering, responsible for the business development in Europe, the US, and Asia. For almost three years, Daniela was involved in the launch and implementation of the life science department in a multinational consulting company, in a project for a large pharmaceutical company in the area of quality assurance with the execution of extensive technical reports of equipment/systems/processes, aligned with GMP. Daniela holds a master’s degree in Molecular Medicine and a postgraduate degree in Pharmaceutical Management.

José C Menezes, PhD, is President and founder of the international company 4Tune Engineering, with offices in Europe (Lisbon) and Brazil (São Paulo). The company is a world leader in science and technology (MS&T) and risk management (QRM) specialising in the pharmaceutical, pharmacochemical, and biopharmaceutical areas. He has been a Professor at the University of Lisbon, Portugal, since 2005, Director of a Programme in Pharmaceutical Engieering running for over a decade, and one of the world's pioneers in the areas of PAT, QRM, QbD, and and KM for pharma and biopharma operations. Jose has 25 years of experience working with pharma companies in Europe, Brazil, and the US.
spacer
Madalena R Testas
spacer
spacer
spacer
Daniela B Santos
spacer
spacer
spacer
José C Menezes
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Injection vials for vaccines for protection against Covid-19

Düsseldorf, July 02, 2020 The vaccines under development to protect against Covid-19 are, like many other drugs, filled in so-called injection or vials made of type 1 borosilicate glass, also known as vials. The large worldwide demand for vials is met by the Gerresheimer Group's plants in Europe, America and Asia, where they are manufactured to high quality standards for customers in the pharmaceutical industry. The Company has already received initial orders for vials for drugs and vaccines against Covid-19.
More info >>

White Papers

Nasal Drug Delivery with a Focus on Chronic Rhino-Sinusitis

Aptar Pharma

Aptar Pharma have hosted a scientific roundtable on “Nasal drug delivery with a focus on chronic rhino‑sinusitis”. This international scientific forum was held in Paris, France on November 13th 2012. The roundtable was organized to explore and exchange views on the science of various forms of sinusitis and its related unmet medical needs.
More info >>

 
Industry Events

12th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology

8-11 February 2021, Vienna, Austria

In continuation of the very successful scientific meetings in Budapest, Paris, Berlin, Florence, Geneva, Barcelona, Malta, Istanbul, Lisbon, Glasgow and Granada, the 12th PBP World will be held in Vienna from 8-11 Feb 2021. This every two year held conference has gained an ever increasing impact among the pharmaceutical scientists: With up to 1000 submitted abstracts and about 1300 participants it has become a well-established major meeting, attracting scientists from all over the world.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement