The US Food and Drug Administration (FDA) has posted a Warning Letter for current good manufacturing practices (cGMP) violations in active pharmaceutical ingredient (API) manufacturing cited at the pharmaceutical manufacturing facility of VUAB Pharma a.s., in Roztoky, Czech Republic. The Warning Letter was issued based on an FDA inspection from June 09, 2014, through June 13, 2014, for human and veterinary APIs. The FDA said that the firm’s response, dated July 01, 2014, lacked sufficient corrective actions and also noted additional correspondence from the firm dated December 18, 2014, and May 07, 2015. The FDA cited problems with quality control and data-integrity issues. 

The FDA cited the firm for failure to adequately investigate and resolve all quality-related customer complaints and to investigate other batches that may have been associated with specific failures. The firm said the company’s quality unit released API with objectionable microbial contamination into distribution. The company was also cited for failure to prevent unauthorized access or changes to data and to provide adequate controls preventing data omissions. The agency said that its inspection noted that the firm did not retain complete raw data from testing performed to assure the quality of specific APIs. Specifically, the inspection showed that the firm did not properly maintain a back-up of high-performance liquid chromatography (HPLC) chromatograms that formed the basis of product-release decisions. The inspection revealed discrepancies between the printed chromatograms and the operational qualification protocol for the HPLC system, which is intended to demonstrate correct operation of the HPLC. These discrepancies included injection sequences and values to calculate relative standard deviation.

The FDA also noted in its Warning Letter that the company failed to have proper controls in place to prevent unauthorized manipulation of the company’s laboratory's raw electronic data. The inspection revealed the company’s HPLC system did not have access controls to prevent alteration or deletion of data. the 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, the agency 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,” said FDA in its letter. “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.”

The FDA has requested that company provide a comprehensive corrective action plan for computer system controls over all laboratory and manufacturing instrumentation and equipment.

Source: FDA