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

Published: August 2020
Pages: 236

• 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 carryover, and cross contamination are controlled, minimized, and monitored to safeguard patient safety and product quality.

Executive Summary

This ISPE Guide offers practical, risk-based strategies to develop, validate, and maintain effective cleaning programs in pharmaceutical manufacturing. It supports regulatory compliance by addressing contamination control through a lifecycle approach to cleaning validation.

What You'll Learn

This comprehensive guide delivers actionable insights into the development of compliant cleaning validation programs across the pharmaceutical lifecycle. Key topics include:

• Application of risk management principles
• Adoption of a lifecycle approach to 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-related issues and operational challenges
• Change management strategies

These topics are critical for ensuring that cleaning processes meet regulatory expectations and align with current best practices in pharmaceutical cleaning validation.

Who Should Use This Guide

This guide is designed for professionals responsible for developing, validating, and overseeing cleaning programs, including:

• Quality assurance and validation personnel
• Regulatory affairs professionals
• Manufacturing and operations engineers
• Compliance specialists
• Risk management teams

It is particularly relevant for organizations seeking to align their cleaning validation requirements with international regulatory standards and industry expectations.

Conclusion

Developed by a team of industry experts, this guide serves as both a reference for the cleaning validation lifecycle and a practical manual for implementing robust cleaning programs. It is aligned with the ISPE Baseline® Guide: Volume 7 – Risk-Based Manufacture of Pharmaceutical Products (Second Edition), providing additional context and depth.

Guide Core Team

Jose Caraballo

VP Quality Systems, Compliance, and Quality Engineering

Kite Pharma, Inc.

Joseph Payne

President & COO

Scorpius Biopharmaceuticals

Elizabeth Dallison

Pfizer Inc

Richard Forsyth

Principal Consultant

Forsyth Pharmaceutical Consulting

Trefor T. Jones

Biopharma Consultant

Blue Hatch Consultancy

Beth Kroeger

Technical Services Senior Manager

Steris Corp.

Samuel Lebowitz

Technical Services Manager

Electrol Specialties Co

Catherine Oakes

Managing Director

Oakes Group Global Ltd.

Fred Ohsiek

Senior Global Technical Manager

Ecolab

David Vincent

Dr.

VTI Life Sciences, Inc.