Analytical Sciences, Invited / Award Lecture

Managing Change in Change Resistant Laboratories

C. Jansen1
1Mettler-Toledo GmbH

"Never change a winning team", - with this motto, many laboratories do not dare to update their processes and procedures according to regulations, technical requirement changes, and software updates. They might not be informed about compliance risks, and opportunities for improvements with state of the art technologies and easier workflows might be missed. The pharmaceutical industry especially is often reluctant to change. This is understandable when you keep in mind the efforts needed in paperwork and re-validation.
Presentations about future trends in laboratories are booming, generating great interest in progressive development, which is in contrast to conservative practices in many laboratories.
With "fit for future" projects, the digital transformation is growing quickly in many labs today. For quality control labs, this is a consequence of regulatory pressure. For R&D labs, this is a question of business benefits and increasing efficiency, reducing cost while improving data quality.
At the end of 2020, US Pharmacopoeia published a Draft General Chapter 1220 with a new method lifecycle model for ISO 17025 and GMP processes. This includes method development as the most important step and recommends leaving enough design space for update flexibility.

[1] Webinar BMD "Method validation"
[2] USP <1220> draft from …