Hướng dẫn của ISPE: Thẩm định vệ sinh (Cleaning Validation)

This ISPE Guide: Cleaning Validation Lifecycle - Applications, Methods, and Controls provides 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

Created by a team of industry experts, this Guide is intended as a reference for the cleaning lifecycle model and a practical guide for applying the theory and concepts to help create compliant cleaning programs. It is aligned with the principles described in the ISPE Baseline® Guide: Volume 7 – Risk-Based Manufacture of Pharmaceutical Products (Second Edition).