| 15/04/05
| Chiron Fluvirin Vaccine License Reinstated
by UK Regulatory Agency |
 |
|
British regulators
have given the go-ahead for Chiron Corp. to resume production
of flu vaccine, ending a five month suspension that caused widespread
shortages. |
The Company plans to begin production immediately in anticipation
of getting clearance from the US Food and Drug Administration so it
can have vaccine available for the flu season starting in the autumn.
In October, the Medicines and Healthcare Products Regulatory Agency
(MHRA) barred the company from shipping to the United States some
48 million doses of its Fluvirin-branded flu medicine made in its
Liverpool factory because of contamination concerns.
Clean Room Construction Ltd was employed to upgrade
and modify the Formulation Suite. The Flu to Market (FtM) Project
was agreed in November 2004 with completion required before the end
of January 2005. Clean Room Construction established
the Project Team led by Jim Muir and supported by Barry Askew on Site.
Specialist sub contractors worked around the clock, including week
ends and the Christmas holidays to complete the modifications, improvements
and total upgrade within the programme.
Upon completion the MHRA said inspectors believed improvements had
been made and the facility now met satisfactory standards.
“The
Company has been informed and is now free to recommence full manufacturing
of the vaccine”, on the condition that it continue to make improvements
at the plant, the agency said.
A great success story illustrating Clean Room Constructions
commitment to its clients.
|
CRC
- Units K1/K2
Temple Court
Knight Road
Strood
Rochester
Kent, UK - ME2 2LT
T: +44(0)1634 295111
F: +44(0)1634 294100 |
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