Earlier guidelines such as ICH Q2(R1) and USP <1224>, <1225>, and <1226> viewed analytical method validation as a discrete activity focused primarily on chromatographic procedures. With ICH Q14, ICH Q2(R2), and USP <1220>, a life-cycle approach now considers variability and improves reliability, supported by tools like DoE, multivariate statistics, and digital technologies enabling Quality by Design and risk-based systems.
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Tag Archive for: PharmaLab 2025
Tag Archive for: PharmaLab 2025
Last year, potency assays as a new conference topic was very well received by attendees. It will therefore be offered again this year. Further, according to the general feedback, there is also a need for conferences on other topics as a platform for exchanging experiences and opinions with colleagues and regulatory representatives. Accordingly, in 2025, three new topics will be addressed in dedicated tracks:
• Bioanalytical Control of Biological Drug Substances and Products
• Quality Control of mRNA/LNP Products (Pre-Conference, 24 November)
• Artificial Intelligence in Laboratories
The established topics will also be covered at PharmaLab 2025 from 24-26 November in Neuss – providing participants with the opportunity to exchange knowledge and experiences with representatives from authorities like EDQM, PEI, NIBSC/MHRA, AGES, industrial experts and scientists from laboratories:
• Analytical Quality and Lifecycle Concepts
• GMP Compliance Trends Analytical Laboratories
• Laboratory Optimization, Automation and Digitalization/Outsourcing in Pharmaceutical Laboratories
• Endotoxin and Pyrogen Testing
• Alternative and Rapid Microbiological Methods
• Cell and Gene Therapies/ ATMPs – Quality and Safety
• Bioassays/Potency Assays – Regulatory Requirements, Developments and Routine Use
• 6th International Mycoplasma qPCR Testing User Day (Pre-Conference, 24 November)
Congress delegates benefit from 9 parallel conferences, 2 pre-conference workshops with altogether over 100 presentations, 50 exhibitors in the exhibition and the networking event. An update in all relevant areas of pharmaceutical lab developments will be provided.
One-day and multi-day tickets offer participants the opportunity to attend parts or even the entire congress and thereby put together an individual programme with the lectures of choice.
More information
Website: https://www.pharmalab-congress.com
eMail: info(at)concept-heidelberg.de


Concept Heidelberg GmbH