VUAB Pharma a.s.

VUAB Pharma a.s..
Product: pharmaceutical manufacturing facility
Date: 5/27/2015

ailure to prevent unauthorized access or changes to data and to provide adequate controls preventing data omissions.

Our inspection noted that your firm did not retain complete raw data from testing performed to assure the quality of (b)(4), API. Specifically, our inspection revealed your firm did not properly maintain a back-up of HPLC chromatograms that form the basis of your product release decisions. Our inspection revealed discrepancies between the printed chromatograms and the operational qualification protocol for the High Performance Liquid Chromatography (HPLC) system, which is intended to demonstrate correct operation of the HPLC. These discrepancies included injection sequences and values to calculate relative standard deviation (RSD).

While investigating these discrepancies, our investigator requested the original electronic raw data. Your quality unit, after consulting with the Information Technology (IT) department, stated they were unable to retrieve the original electronic raw data because back-up discs were unreadable. Your quality unit then stated that back-up disks have been unreadable since at least 2013. Your HPLC system is used to test (b)(4), API for batch release. However, without complete, accurate, reliable, or retrievable raw data about the HPLC system?s qualification, you lacked complete assurance that the system was operating as intended.

You also failed to have proper controls in place to prevent unauthorized manipulation of your laboratory?s raw electronic data. Our inspection revealed your HPLC system did not have access controls to prevent alteration or deletion of data. Your HPLC software lacked an audit trail recording any changes to the data, including: previous entries, who made changes, and when changes were made. During the inspection, we also noted that all laboratory employees shared a common log-in and password to access the system.

This lack of control over the integrity of your data raises questions about your analytical data?s authenticity and reliability, and about the quality of your APIs. We note that the September 2008 FDA inspection uncovered concerns over your handling of raw analytical data, including discrepancies between laboratory notebooks and printed chromatograms.

Your response states you are qualifying a new HPLC system which allows operator-specific passwords and has audit trial and back-up functions. Your response also states you will implement a new electronic back-up system in your QC chemistry department.
However, your response lacks sufficient detail about systems and controls you will implement. Simply activating audit trail functions and instituting password controls is inadequate. In addition, you failed to review historical data to ensure the quality of your products distributed to the US market.

In your response to this letter, provide a comprehensive corrective action plan for computer system controls over all laboratory and manufacturing instrumentation and equipment. This response should include but not be limited to:

Information regarding changes in the reliability of your information technology infrastructure, including but not limited to improved computer systems, systems validation, revised procedures, and appropriate retraining of employees that will be implemented immediately to ensure your firm creates and retains complete and accurate electronic raw data.
Your firm’s procedure for the establishment, issuance, and control of passwords used to access your analytical instrumentation. All access levels for computerized systems should be clearly defined and documented in a written procedure.
A detailed summary of the steps taken to train your personnel on the proper use of computerized systems.

FDA District Office: CDRH

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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