News about GMP/cGMP

31.01.2017

FDA: Warning Letter for UK Drugmaker

The US Food and Drug Administration (FDA) already issued 7 Warning Letters in 2017, one of which went to Porton Biopharma Limited in Salisbury, United Kingdom. The UK-government owned manufacturer of biopharmaceutical products was inspected from March 7 to 18, 2016 and previously on January 12 to 23, 2015. Both inspections resulted in similar violations and a Form 483.

 

The warning letter dated January 19, 2017 summarizes significant violations of current good manufacturing practice (CGMP) for finished pharmaceuticals, 21 CFR parts 210 and 211, and significant deviations from CGMP for active pharmaceutical ingredients (API). The issue of concern is Erwinaze®, an orphan biologic developed by Porton and licensed to Jazz Pharmaceuticals.

"These repeated failures demonstrate that management oversight and control over the manufacture of drugs at your facility is inadequate, and that your previous corrective actions did not address persistent contamination hazards and drug quality issues," FDA writes.

Here are some observed violations and deviations:

  • Failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
  • Failure to establish and follow appropriate written procedures, designed to prevent microbiological contamination in drug products purporting to be sterile (21 CFR 211.113(b).
  • Failure to establish and follow change controls to evaluate all changes that could affect the production and control of intermediates or API.
  • Quality Agreement violations towards Jazz Pharmaceuticals.

Now it is up to Porton Biopharma to respond to the letter within 15 business days and to specify the corrective action taken. A face-to-face regulatory meeting between Porton, Jazz Pharmaceuticals and  Agency officials will be scheduled.

Click here to read the lengthy warning letter to Porton Biopharma.


Source:

FDA: 2017 Warning Letters

 



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