Apr 23, 2022

If your equipment is not clean and it's non-dedicated. Then what do think the quality of your product will be impacted or not?

Book your copy of Blue Ocean of Compliance todayIf your equipment is not clean and it's non-dedicated. Then what do think the quality of your product will be impacted or not?
Whether cross-contamination will have an impact on your product quality or not?

In one Case Study
FDA investigators observed that the cleaning validation studies for many critical, non-dedicated equipment with direct drug product contact surfaces were incomplete.
During the inspection, the firm was unable to provide adequate justification that current cleaning procedures adequately remove drug residues and prevent cross-contamination.

If there are cleaning procedures but if they also do not fulfill the regulatory requirement then?

As per the regulator firm’s cleaning procedures lacked adequate specificity and detail to be performed consistently and be validated.

For example, standard operating procedure (SOP) “Procedure for Cleaning,” Section xyz contained instructions to ......are an example of product contact equipment that is extremely difficult to clean and is therefore usually dedicated to a specific drug product.

As per the regulator firm did not have scientific data that visibly clean does not result in carryover of drug residues from one drug product to another.

Additionally, cleaning to remove only visual residue is inadequate.

Non-visible residues, including those from the cleaning process itself, must also be adequately removed. The firm must have adequate and validated cleaning procedures.

What did you conclude from this discussion?