Mandatory requirement for quality control of medicinal products in the European Member States who exported to the European market more
Weighing in compliance with European Pharmacopoeia
Weighing requirements according to the Ph. Eur. 2.1.7 “Balances for analytical purposes”
The new European Pharmacopoeia (Ph. Eur.) General Chapter 2.1.7 “Balances for Analytical Purposes” is a mandatory requirement for the quality control of medicines in European member states, or for 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. 2.1.7 requirements describe 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.
This white paper describes the weighing requirements according to the European Pharmacopoeia General Chapter 2.1.7 “Balances for analytical purposes”. Compliance with calibration, performance checks and the life-cycle management defined within this chapter is mandatory when working according Ph. Eur. monographs.