The Requirements of USP and European Pharmacopoeia
USP and Ph. Eur. chapters are legally binding for all pharmaceutical companies in the US and Europe as well as companies that import pharmaceutical products to the US and Europe. As such, USP and Ph. Eur. requirements are enforced in the framework of GMP audits performed by regulatory bodies.
Both chapters focus on lifecycle management of analytical balances used for quality control of drugs and state that calibration is mandatory.
In this webinar we will help to guide you through the topic of European Pharmacopoeia Chapter 2.1.7 and USP in relation to weighing, covering:
- The need for minimum weight and the requirements of USP/changes to Ph.Eur regarding balances
- What are the implications and requirements relating to weighing?
- Controlling and improving performance
- Calibration and certification
- Routine testing
- Good Weighing Practice™ (GWP®)