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

Guide: Cleaning Validation Lifecycle – Applications, Methods, & Controls cover image

Title:

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

Author(s):

Caraballo, Jose; Dallison, Liz; Forsyth, Rich; Jones, Trefor; Kroeger-Fahnestock, Beth; Lebowitz, Sam; Oakes, Catherine; Ohsiek, Fred; Payne, Joseph; Rizwan Sharnez, Rizwan, PhD; Vincent, David W., MPH, PhD

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Author(s): Caraballo, Jose; Dallison, Liz; Forsyth, Rich; Jones, Trefor; Kroeger-Fahnestock, Beth; Lebowitz, Sam; Oakes, Catherine; Ohsiek, Fred; Payne, Joseph; Rizwan Sharnez, Rizwan, PhD; Vincent, David W., MPH, PhD

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 are controlled, minimized, and monitored to safeguard patient safety and product quality.

This ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controlsprovides 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).

Table of Contents

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

Full Title: ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls
Pages: 236