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1. FDA expects firms to have written standard operating procedures (SOP) detailing the cleaning process used for various pieces of equipment.
2. If firms have a specific cleaning process for cleaning between different batches of the same product and use a different process for cleaning between product changes, FDA expects the written procedures to address these different scenarios.
3. If firms have one process for removing water-soluble residues and another process for non-water soluble residues, the written procedure should address both scenarios and make it clear when a given procedure is followed.
4. It is required by the FDA, in the general validation procedure, that the personnel responsible for performing and approving the study should comply with the acceptance criteria and the revalidation data.
5. FDA expects firms to prepare specific written validation protocols in advance for the studies to be performed on each manufacturing system or piece of equipment which should address such issues as sampling procedures, and analytical methods to be used including the sensitivity of those methods.
6. It is expected that firms conduct the validation studies in accordance with the protocols and document the result of studies.
7. Final validation report is to be approved by the regulatory board which states whether or not the cleaning process is valid.
