A Pharma Guide to Cleaning Validation

Excerpt from the GMP Compliance Adviser

Does your cleaning validation meet the current requirements of Annex 15 to the EU GMP Guidelines? And are you already familiar with the new requirements for establishing limits in cleaning validation?

Michael Hiob, a German Ministerial Pharmaceutical Director and former GMP inspector, gives a comprehensive overview on agency expectations and tells you how to set up a risk-based cleaning validation in consideration of the lifecycle approach for products and processes.

Dr. Jens Hrach, toxicologist, explains what the new PDE approach is about and points out its implications for cleaning validation.

Cleaning validation is not new, but the official requirements were updated in the revised Annex 15 in order to reflect the current state of the art. Three aspects are in the foreground:

• The lifecycle of the process should be taken in consideration.
• A quality risk management approach should be applied.
• Limits for the carryover of product residues should be based on a toxicological evaluation (PDE report).

The Pharma Guide to Cleaning Validation will show you exactly what 'done correctly' is. The report includes:

• Regulatory aspects
• Cleaning process requirements
• Risk management
• Design phase
• Validation phase
• Ongoing verification/revalidation
• Documentation
• PDE Guideline of the EMA
• Calculating the maximum allowable carryover
• Visually clean
• Microbiological state

Every page offers practical strategies to implement an up-to-date cleaning validation and meet regulatory requirements.