METTLER TOLEDO (Switzerland) - Ensure Compliance with Ph. Eur. General Chapter 2.1.7.
This webinar explains everything you need to know about the new Ph. Eur. General Chapter 2.1.7 "Balances for Analytical Purposes". The European Pharmacopoeia is a legally binding reference for the quality control of medicines in its European member states, or any pharmaceutical company who exports into the European market.
It has a similar legal status to the USP compendium in the United States. Ph. Eur. requirements include the same tests and criteria as USP General Chapter 41, but Ph. Eur. explicitly states that calibration should include measurement uncertainty and emphasizes the concept of as-found and as-left calibration.
In this webinar you will learn:
- The legal status and scope of the European Pharmacopoeia
- The key elements of General Chapter 2.1.7 "Balances for Analytical Purposes"
- The similarities and differences between Ph. Eur. and USP requirements
- The main weighing principles and considerations to mitigate environmental influences that might affect the performance of the balance
- Why calibration is an essential task in a quality management system, and must include a statement of measurement uncertainty
- The specific performance checks required to assess the accuracy and precision of an instrument
- How GWP, a scientific standard, supports compliance with General Chapter 2.17
- Where to obtain further information on the life-cycle management of balances in a regulated environment.
Klaus Fritsch, Compliance Manager