La centrale de pesée est un des points sensibles des unités de production : l’ensemble des composants servant à la fabrication y est soigneusement identifié et pesé. Quel que soit le mode de pesage, PHARMACIM® assure l’identification des matières, le contrôle du poids, les réconciliations par lot de fabrication, le suivi des instruments de pesage.
Ce module est basé sur l’exécution de procédures autorisant :
- le vide de box,
- l’étalonnage balances,
- les pesées (différents modes),
- la réconciliation,
- la réservation matières.
Conformité CFR title 21
Section 211.68
Automatic, mechanical or electronic equipment… may be used in the manufacture, processing, packing and holding of a drug product. If such a product is so used, it shall be routinely calibrated, inspected or checked according to a written program designed to assure proper performance.
Section 211.101
Components for drug products manufacturing shall be weighed, measured and subdivided as appropriate. If a component is removed from the original container to another, the new container shall be identified with the following information :
1/ component name or item code
2/ receiving or control number
3/ weight or measure in new container
4/ batch for which component was dispensed including its product name, strength and lot number.
Weighing, measuring or subdividing operations for components shall be adequately supervised. Each container of component dispensed to manufacturing shall be examined by a second person to assure that :
1/ the component was released by the quality control unit
2/ the weight or measure is correct as stated in the batch production records
3/ the containers are properly identified<