GXP

Is Swabbing a Regulatory Requirement? | IVT

Swab sampling is a direct surface sampling technique for sampling surfaces Personnel who perform swab sampling should be qualified for performance Swab efficiency (i.e., % recovery) for the method and product contact material should be determined Extractables from the swab or protein binding to the swab must not interfere with the method Swab sampling has advantages and disadvantages Global regulatory guidelines describe various direct, indirect, or alternative sampling methods for cleaning validation Methods used should be appropriate for their intended use Methods used should be based on process...

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