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6. Minimum weight according to European Pharmacopoeia PE
Today, there are no specific requirements in the European Pharmacopoeia EP for weighing procedures, and there are no defined tests and evaluation criteria to qualify a balance for the procedures stipulated in the EP monographs.
On December 18, 2019, the European Pharmacopoeia (EP) published a draft Balances chapter for its compendium. The EP is the single reference for quality control of medicines in 38 European countries, including all EU member states as well as Iceland, Norway, Serbia, Switzerland, Ukraine, Turkey and others. All pharmaceutical industries in these countries, and those importing into them, must comply with the applicable chapters of the EP.
A group of experts from pharmaceutical companies, including two manufacturers and EP representatives, have drawn up the requirements and best practices in the new Balances chapter....
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Minimum weight according to European Pharmacopoeia PE
Minimum weighing according to Euramet guide
Bibliography
- (1) - SFSTP - Quand la pesée minimale prend des proportions énormes ou la pesée minimale et ses conséquences. - Revue STP Pharma Pratiques, volume 16, n° 1, janvier/février 2006.
Also in our database
Standardization and standards
- Quality management systems – Requirements - ISO 9001 - 2015
- Exigences générales concernant la compétence des laboratoires d'étalonnages et d'essais. - ISO/IEC 17025 - 2017
- Measurement management systems – Requirements for measurement processes and equipment. - ISO 10012 - 2003
- Détermination de l'incertitude de mesure pour les mesurages volumétriques effectués au moyen de la méthode gravimétrique....
Organizations
European Directorate for the Quality of Medicines & healthcare EDQM http://edqm.eu
- Balances - Pharmeuropa 32.1 - Projet de chapitre 2.1.7
- Balances - GC <41> - 2014
- Weighing...
United States Pharmacopeia USP http://www.usp.org
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