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.