European Pharmacopoeia (Ph. Eur.) General Chapter 2.1.7 Balances for Analytical Purposes was published in July 2021. Compliance with this chapter by January 1, 2022 is mandatory for any pharmaceutical company who manufactures in, or exports into, the European market.
Balances for Analytical Purposes aims to ensure quality control of medicines in European member states. The requirements of Ph. Eur. are similar to United States Pharmacopeia (USP) General Chapter 41. A new white paper “Weighing According to Ph. Eur.” describes the requirements and implications of Chapter 2.1.7 and explains how to ensure compliance.
This whitepaper explains:
- Requirements of Ph. Eur. Chapter 2.1.7 for weighing instruments
- Scope of regulations, for quality control and analytical processes
- The importance of calibration, including a statement of measurement uncertainty
- Which performance checks and criteria are used to assess accuracy and repeatability
- How to determine appropriate testing intervals
- How to prove compliance with the appropriate documentation and certificates
- Make sure that your weighing processes are fully compliant with the new requirements by January 1, 2022
Download the whitepaper here.
