ePT--the Electronic Newsletter of Pharmaceutical Technology
On Dec. 20, the US Food and Drug Administration posted a
Warning Letter issued Sept. 28 to Nephron Pharmaceuticals Corp. (Orlando, FL, www.nephronpharm.com) by the agency's Florida District Office (Maitland, FL).
The warning cited the respiratory-therapy company for failing to adequately report postmarketing adverse drug experiences (PADEs) and for lapses in current good manufacturing practice (CGMP) in the production of albuterol sulfate inhalation solution, ipratropium bromide inhalation solution, racepinephrine inhalation solution, and sodium chloride inhalation solution.
The cited CGMP deficiencies included: lack of written provisions for reviewing complaints; failure to investigate batch failures or discrepancies; failure to establish process controls for identity, strength, and purity; deviations from established specifications without justification;, and lack of calibration and inspection records for manufacturing equipment.
FDA's warning letter did indicate that the company's May 25 response "appears to be adequate," but also said, "we are concerned that your firm may not fully understand the role of the quality control unit in your overall manufacturing process."
Training and mock audits are the key to preventing data integrity issues with partners offshore, but the process must start at home. Compliance consultant John Avellanet shares best practices and ways to minimize costs.