Spanish heparin manufacturer draws the ire of the FDA in its latest warning over quality concerns

21 Jul 2022
endpts.com
Spanish heparin and API manufacturer Bioiberica is still not in the clear as far as the FDA is concerned, with a new warning letter related to contamination concerns. The US regulator initially issued a Form 483 to the Spanish drugmaker’s manufacturing plant in Palafolls, north of Barcelona. In an FDA inspection between Jan. 31 and Feb. 4 this year, the regulator found several major issues related to cleaning and contamination and a lack of control procedures among other observations. The agency has now issued a warning letter concerning significant deviations in cGMP for active APIs at the facility. The letter , dated June 30, acknowledges that Bioiberica had responded to the Form 483, but the FDA was not satisfied. First, the FDA had concerns over Bioiberica’s failure to establish written procedures to monitor the progress and control the performance of processing steps. The initial inspection saw around 23 batches of APIs needing to be reworked in 2020 and 2021 due to microbiological contamination. Bioiberica responded that they agreed that there was inadequate control and monitoring of processes, and committed to validating the microbiological contamination reduction process, however, the FDA found this response inadequate. “The use of equipment that is not part of the validated manufacturing process is considered rework. In addition, you failed to provide interim measures to ensure your manufacturing process can adequately reduce microbiological contamination.” the letter said. Bioiberica also failed to provide corrective action to address a lack of process controls. The letter demands a response for an assessment of its API manufacturing process, including rework activities performed, to ensure that there is a data-driven and scientifically sound program that identifies and controls all sources of variability. Bioiberica must also provide timelines for completing process performance qualification studies and a comprehensive, independent assessment of the design and control of its manufacturing operations, with a detailed and thorough review of all microbiological hazards. The FDA also noted that the company failed to ensure that reworked batches were subjected to evaluation and stability testing as none of the company’s reworked batches were placed on stability to ensure they were of the same quality. The company’s response committed to developing impurity profile parameters and stability-indicating analytical methods but failed to provide interim measures until those methods are installed and need to show to the FDA. Additionally, the reworked batches currently on the market have not been evaluated. The company also does not have an adequate program for monitoring process controls as well. The letter recommends that Bioiberica engage a cGMP consultant and further investigate any other issues. Any continued failures and the FDA may withhold approval of new applications or supplements listing it as a drug manufacturer until any deviations are addressed and in compliance. The FDA may also re-inspect as well. Failure to address any of these issues may also result in the FDA refusing admission of articles manufactured at Bioiberica. The company, which did not immediately respond to a request for comment, had 15 days from June 30 to respond to the letter.
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