Spolana a.s Active Pharmaceutical Software Val

The _____ systems calibrated by an outside contractor did not include verification of the precision (% RSD) of the autoinjector at more than one injection volume, the flow rate below 1 ml/min, or the wavelength accuracy for the wavelength regions used for testing of _____. In addition, the _____ software programs had not been verified or validated.

Your response reports that the calibration of analytical instruments will be compIeted December 31, 2000. In addition, you indicate that you will develop a complex _____ software validation schedule in cooperation with thee _____ software vendor by December 31. However, this validation schedule will not be approved by Spolana until January 31, 2001 and the software validation exercise will not be completed until June 30, 2001.
In essence, it appears that you are proposing to continue to use these _____ systems for testing of _____ without having completed the calibration of the
_____ or validation of its software.

This is unacceptable. FDA expects companies to complete calibration of instruments and validation of cal methods before use in order to demonstrate that the analytical instrument and procedures are suitable for their intended use. All analytical procedures are of equal importance from a validation perspective. In general, validated analytical procedures should be used, irrespective of whether they are used for in-process, release, acceptance, or stability testing. Please indicate in your response what actions you plan to take to address this serious CGMP issue.

Your response states in order to prevent recurrence of using analytical test methods for product release testing which has not been validated, Spolana is revising relevant procedures such as change control of analytical methods, change control of specifications, etc. to provide more efficient Q.A. control and supervision on analytical method validation. While this is an appropriate plan of action, the commitment remains questionable in light of other responses related to the completion of instrument calibration and software validation, and the requalification of in-house working standards, which promise delayed completion dates with no interim action to meet CGMP requirements. Please clarify this issue in your response to this letter and clearly specify what actions you have taken or are planning to take to prevent the testing and release of ______ batches using uncalibrated
instruments or equipment or invalidated analytical methods.
FDA District: Maryland

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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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