Dr Joachim Ermer, Sanofi, Frankfurt, Germany
According to EU GMP Guide Part 1, Chapter 6, Quality Control and US 21 CFR 211.160, analytical procedures must be designed to ensure that drug products meet the quality standards and the specifications with respect to strength and purity defined in the marketing authorisation. This includes a suitable control of analytical procedure components such as reagents, solvents, standard and sample preparations to ensure an accurate and reliable analytical result. Thus, the shelf-life and storage conditions of standard and sample solutions should be demonstrated, as discussed in the USP General Information Chapter “Verification of compendial procedures“.
The webinar targets executives and staff in quality control laboratories and quality assurance, who want to get an overview on GMP requirements with respect to stability and expiry dating of reagents, solvents, standard and sample preparations, as well as their efficient practical implementation.