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

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

International Society for Pharmaceutical Engineering, 08/01/2020

851,00 €

Détails

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 management
Adoption of a lifecycle approach for cleaning validation
Cleaning methodologies
Creation of cleaning validation acceptance criteria
Determination of visual inspection limits
Calculation and justification of residue limits
Validation of testing and sampling methods
Equipment issues and challenges
Change Management

Informations supplémentaires

Auteur International Society for Pharmaceutical Engineering
Edité par ISPE
Type de document Manuel
Thème /subgroups/36280
Nombre de pages 236
Mot-clé ISPE Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls