Collecting Samples and Establishing Limits for Cleaning Validation
GMP regulations require that equipment used in the manufacturing of a drug, medical device, or biologic product be cleaned in such a way as to ensure that the quality, purity, and safety of a product will not be adversely affected. This course explains methods in which to collect samples and the need for establishing limits of cleanliness in cleaning validation. Topics in this course include: Locations, Methods, Pros and Cons, Approaches, Influencing Factors, and Documentation. After completing this course, you will be able to identify the advantages and disadvantages of common sampling methods. You will also be able to recognize the need for established limits of cleanliness in cleaning validation, as well as be able to utilize formulas to derive safe, practical cleaning limits.
After this course learners will be able to identify advantages and disadvantages of commonly used sampling methods. recognize the need for established limits of cleanliness in cleaning validation. recognize how to utilize formulas to derive safe, practical cleaning limits.