How to Sampling in Cleaning Validation in the Pharmaceutical – Step by Step
Cleaning validation sampling in the pharmaceutical industry has been a subject of increasing interest and scrutiny in recent Food and Drug Administration (FDA) inspections. The validation of the procedures used to clean the equipment used during the different steps of a manufacturing process is a clear requirement of current Good Manufacturing Practices (cGMP). For example, FDA inspectors now expect to see a cleanliness validation program in place with the proper documentation in place during their inspections.
The objectives of this article are to establish a broad basis for sampling in cleaning method validation policies and programs and to determine the requirements, procedures, acceptance limits, and working documents necessary to support this critically important activity.
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