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
By completing/passing this course, you will attain the certificate of Completion.
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