Us Fda Guidelines

FDA, in its guidelines for cleaning validation, has clearly expressed expectations that industries have to fulfill. The basic requirements, as per FDA, are as follows:

1. A written procedure on how cleaning processes will be validated

2. Clearly outlined responsibility for performing and approving validation study, acceptance criteria, and revalidation requirement

3. Approved written protocols describing the study to be performed, system or piece of equipment, sampling procedures, testing methods, and so on

4. Execution of the protocols in accordance with the written commitment and recording of the results

5. A final validation report with all available data, duly approved by higher management, declaring whether or not the process has been successfully validated

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