Cleaning Validation

About the Course

This eLearning module on Cleaning Validation offers a clear understanding of what constitutes “clean” in pharmaceutical manufacturing, the types of soil, and the modes and agents used for effective cleaning. It guides learners through the design and execution of cleaning validation, including creating a CV master plan, setting acceptance criteria, selecting analytical methods, and conducting recovery studies. The module also addresses regulatory expectations, common deficiencies, and best practices to ensure compliance and maintain product quality.

 Content
 1.Understanding Cleaning
-Meaning of Clean and Soil
-Modes of cleaning action
-Cleaning agents, physical and chemical
-Cleaning process overview and control

 2.Cleaning Validation
-CV: Design and Execution
-Performing Cleaning Validation
-Creating a CV team and CV master plan (CVMP)
-Collecting Information (Product, Equipment & Process Attributes)
-Grouping of products
-Carryover limits and acceptance criteria
-Sampling and sampling sites
-Selecting the right analytical method: about analytical methods
-Recovery studies
-Engineering Study: Pre validation cleaning trial
-Validation Summary Report
-Implementation and Monitoring

 3.Regulatory Observations
-Common deficiencies
-Regulatory requirements and observations

 4.Summary and Conclusion: Importance of cleaning validation in drug manufacturing

5.Final Evaluation: 3 attempts to achieve the passing score in the evaluation