ISPE Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 08/01/2020

Full Description

Regulatory agencies expect the development and validation of a compliant cleaning program. This critical activity ensures that the risks of contamination, product carry over, and cross contamination is controlled, minimized, and monitored to safeguard patient safety and product quality.

This ISPE Baseline Guide: Cleaning Validation Lifecycle: Applications, Methods, and Controls provide a hands-on approach to support the life science industry in the development and establishment of compliant cleaning programs that meet or exceed regulatory expectations. Topics covered include:Application of risk managementAdoption of a lifecycle approach for cleaning validationCleaning methodologiesCreation of cleaning validation acceptance criteriaDetermination of visual inspection limitsCalculation and justification of residue limitsValidation of testing and sampling methodsEquipment issues and challengesChange Management

Product Details

Published: 08/01/2020 Number of Pages: 236 File Size: 1 file , 7.9 MB