Addresses maintenance of the validated cleaning state through ongoing verification, performance trending, deviation and failure investigation, change control, revalidation assessment, periodic review, and documented evaluation of continued cleaning-process effectiveness.
Successful completion of cleaning validation establishes that an approved cleaning process can reproducibly achieve its defined acceptance criteria under the conditions represented by the validation study. It does not eliminate the need to confirm that the process continues to perform…
Cleaning-validation deviations and unacceptable residue results require investigation because they can indicate anything from a documented execution error to a genuine loss of cleaning-process capability. The investigation should determine what actually occurred, whether the original result remains valid, whether the…
Cleaning validation remains valid only while the assumptions, equipment, products, cleaning procedures, acceptance criteria, sampling methods, analytical methods, and operating conditions represented by the validation remain applicable. Change control provides the formal mechanism for determining whether a proposed or observed…
Cleaning validation should remain supported by current evidence throughout the life of the manufacturing process. A validation study completed several years earlier does not by itself demonstrate that the original assumptions still represent the current products, equipment, cleaning procedures, analytical…