Bernafon-MAICO Inc. 5/06/97

“Computer Validation
The inspection found that the xxxx Computer System, used to add bulk quantities of solvents to the manufacturing processes (from a tank farm) for Ticlopidine and Bromocryptine Mesylate drug substances has not been validated (FDA-483 Item #16).

The response to FDA-483 Item #16 is inadequate. Your firm’s commitment is to revalidate the system “to add bulk quantities of solvent to the manufacturing processes for Ticlopidine and Bromocryptine Mesylate drug substances.” The response fails to address how your firm intends to demonstrate that the xxxx Computer System will not allow the operator to add the “wrong” solvent to a particular batch. FDA expects validation data to support such issues.
The response to FDA-483 Item #16 also states, “Until validation is complete an operator will check and record the quantity of bulk solvent that has been added to the manufacturing process”. Please describe in detail, how the operator will be verifying the appropriate amount of solvent. In addition, will the operator be able to identify which solvent was added?

Please provide a copy, of the validation protocol for the xxxx Computer System. Upon completion of the validation, we would like a copy of the final validation report.
SoftwareCPR keywords: CDER, drugs, Pharmaceutical, software validation