Cambrex receives FDA approval for Iowa site
The thumbs up for the Iowa site closely follows European Union (EU) accreditation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its efforts in adhering to the principles and guidelines of good manufacturing practice (GMP).
Cambrex reported that the US Food and Drug Administration inspected the facility for four days from March 23 to March 26 of this year.
‘The facility was inspected and the quality systems used for manufacturing and release of APIs and food grade products were audited in detail for compliance,’ Cambrex said.
A general inspection by the authorities found the Charles City site to fully comply with the latest GMP principles and guidelines.
Cambrex also noted that, ‘there were no Form 483 observations made.’
Form 483 is a list of observations made by the FDA during the inspection of the facility. They are inspectional observations, and do not represent a final agency determination regarding the company’s compliance.
Quality control
Earlier this month, Teva Pharmaceutical Industries were given a Form 483 for its role in failing to correct manufacturing practices.
Reuse of syringes and vials of the anaesthetic propofol is believed to have caused of a 2008 outbreak of hepatitis. Along with Baxter Healthcare Services both were required by a court to pay a total of $500m (€408m) in fines for infecting patients.
Teva voluntarily recalled propofol made in California after 41 patients developed post-operative fever and other symptoms the company said may have indicated exposure to bacterial toxins.
Likewise, biotech giant Genzyme, Johnson and Johnson McNeil and Sun Pharmaceuticals' unit Caraco have been cited by the FDA for failing to establish and follow written procedures to ensure GMP.
“The Cambrex Charles City staff has demonstrated our commitment to adhering to the highest quality standards in the manufacture of APIs,” said Joe Nettleton, vice president operations and Charles City site director.
“We work diligently to maintain high quality standards and we have once again demonstrated our efforts to sustain and continuously improve quality platforms within Cambrex,” he added.
The FDA and the EU-GMP are the main regulatory bodies and are responsible for setting out and updating regulations as research necessary to keep up with new drugs and products.
For each step in the manufacturing, processing and packaging of items under GMP jurisdiction, specific criteria must be satisfied to make sure that drugs, medical products and blood supplies are safe for public use.
