ISPE基准指南:清洁验证生命周期–应用,方法和控制

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ISPE基准指南:清洁验证生命周期–应用,方法和控制(英文版)

guide-cleaning-validation-lifecycle

Published: August 2020

Pages: 236


Bound version will ship after 18 September 2020

Table of Contents

Special Pricing for Emerging Economies

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 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).

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