Castillo CA, Vargas HG

Language: Spanish
References: 0
Page: 93-101
PDF size: 338.06 Kb.

ABSTRACT

Among critical systems at the Center of Molecular Immunology is the channel of conductivity measurement for both purifi ed water (PW) as for water for injection (WFI). In accordance with the Good Manufacturing Practice compliance, these systems are regularly subjected to validation processes, where the calibration of conductivity channel is a mandatory practice for performance qualifi cation. An equipment or system of measurement to be reliable requires a conformity assessment with a probability greater than or equal to 95%. The compliance in accordance with regulatory requirements and current guidelines conformity assessment in the calibration of PW and WFI system is proposed as a criterion. The calibration procedure and the current international pharmaceutical regulations for water conductivity measuring for injectable products are harmonized. The metrological characteristics are defi ned, sources of uncertainty are quantifi ed and acceptance intervals are determined, to achieve a probability of the Conformity in the calibration equal to 95% from knowledge of measurement capability, in order to respond to requirements of international regulatory agencies for the biopharmaceutical industry.