Cleaning Qualification

This course of four chapters will give you a sound basis of the regulatory requirements expected of a good pharmaceutical cleaning process, how to calculate limits and their justification. The pros and cons of various cleaning methods and how to approach them. Finally, how to plan and approach a validation exercise with specific cleaning acceptance criteria.

To discuss and review:

• Regulatory expectations for cleaning validation
  • EudraLex chapters 3 and 5
  • Annex 15 requirements
• Health-based exposure limits, how they are determined, the data needed to support these limits and what the health-based exposure limit is used for with regards to cleaning qualification
• Different approaches to the qualification and potential validation of manual and automated cleaning procedures