Webinar: Stability of Test Solutions

Webinar: Stability of Test Solutions

Course No 18029


Costs

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Speakers

Dr Joachim Ermer, Sanofi, Frankfurt, Germany

Background

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 <1226>“Verification of compendial procedures“.

Target Group

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.

Programme

Besides regulatory expectations, the Webinar provides recommendations with respect to stability investigations of test solutions for qualitative and quantitative use. Suitable stability study designs, data calculations and assessments will be presented, in order to achieve a reliable and traceable shelf-life Determination.

The following topics will be covered:
  • Requirements to solutions for qualitative and quantitative use
  • Correspondig addition to USP General Information Chapter <1226> “Verification of compendial procedures“ (valid December 1, 2019)
  • What changes are acceptable for qualitative and quantitative use?
  • Appropriate evaluation of stability results. Why is the assessment of individual results not suitable?
  • Evaluation of stability data by averaging and regression
  • Determination of the shelf-life of standard and sample solutions

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