FDA cites computer monitoring system, data review and sterility issues at Solvay.

Zooming in on a computerized monitoring system, lab data review and sterility, the Center for Drugs Division of Manufacturing and Product Quality slapped Solvay Pharmaceutical's sterile drug manufacturing facility in Olst, The Netherlands, with a June 23 warning letter.

Among the areas of concern were a computer system for monitoring temperatures, conductivity and water pressure. FDA said Solvay had not validated the system. The company also used an uncalibrated unit for com-paring computer-line and equipment air pressure measurements, the letter stated. In addition, the agency objected to the practice of monitoring "the differential air pressure for aseptic filling areas and the surrounding support areas" at rest, not under dynamic conditions.

The letter hit data review on two points. Citing the lack of a system for reviewing microbiological lab data, FDA said this led to delays in review. Noting that the responsible pharmacist released products based only on computer data, the agency expressed concern that products might be released to the market without a secondary review of raw data.

Sterility problems included inadequate validation of the autoclave; deficiencies in the use of biological indicators (BIs) to verify sterilization cycle effectiveness; and problems with media fill procedures.

FDA termed the company's response inadequate and requested information on plans for monitoring while the computer system was being validated, a copy of the autoclave validation protocol and procedure for raw data review, plus an English translation of the BI analysis procedure.

Describing the points raised in the warning letter as "the most significant GMP deviations" uncovered during the audit, the agency also requested explanations of differences between verbal and written responses to observations not detailed in the letter.

FDA recommended that Solvay evaluate the facility for overall GMP compliance. The agency will not recommend approval of any applications listing the firm as a sterile drug product supplier until compliance is confirmed, the letter added.

As of deadline, efforts to obtain a comment or update from the firm were unsuccessful. Investigators Thomas Arista and Analyst Robert Tollefsen audited the plant Feb. 19-25.