Chiron passes FDA's inspection of UK facility
Following its July 2005 GMP inspection of Chiron Corporation's Liverpool facility, which manufactures the Fluvirin influenza virus vaccine, the US FDA has declared Chiron's responses and proposed corrective actions to a previous inspection to be 'generally acceptable'.
Following its July 2005 GMP inspection of Chiron Corporation's Liverpool facility, which manufactures the Fluvirin influenza virus vaccine, the US FDA has declared Chiron's responses and proposed corrective actions to a previous inspection to be 'generally acceptable'.
This outcome, coupled with the conclusion by the UK Medicines & Healthcare products Regulatory Agency (MHRA) in March 2005 that Chiron could conduct operations in accordance with GMP, means the company may proceed with its efforts to return the Fluvirin vaccine to the US market for the 2005-2006 influenza season.
'The Fluvirin remediation plan called for unprecedented communication and co-operation between the FDA and the MHRA. Chiron has now achieved a key milestone in this remediation effort. We are grateful for the direction and guidance the regulatory agencies have extended to us throughout this process,' said Howard Pien, ceo at Chiron.
The remediation plan introduced a number of improvements to the facilities, equipment and processes, meaning that Chiron had to receive supplemental approvals from the FDA before it could supply Fluvirin to the US market. In addition, the company's ability to deliver the vaccine to the US will depend upon successful production and final testing of the vaccine, as well as release of the vaccine by the FDA.
The company expects that the MHRA may inspect its Liverpool facility again before it commences shipment. The FDA will evaluate the implementation and effectiveness of Chiron's corrective actions and assess its overall compliance at its next routine GMP inspection of the facility.