Changes are made at Charleston, SC, and Wilmington, NC, facilities to meet MHRA guidelines.
AAIPharma reports that it completed over $2 million worth of upgrades to its parenteral manufacturing facility in Charleston, SC, and its sterile product release operation in Wilmington, NC.
“Although the facility is already fully U.S.-FDA compliant, this upgrade positions the Charleston facility to meet the expectations of the MHRA in the U.K.,” comments Lee Karras, AAIPharma senior vp of North American pharmaceutical operations. “This is of particular importance to customers who wish to conduct clinical trials in the EU as well as export marketed product to the EU.”
Improvements were made to increase capacity and to ensure compliance with EU aseptic processing and testing guidelines, positioning the facilities to be approved for aseptic filling and release of products exported to the EU, notes a company official.
The upgrade in the Charleston facility significantly improves the plant's material and people flow as well as enhances the HVAC capacity for greater control of the plant environment, adds Karras. To support sterile product release for material to be supplied in the EU, the Company has also added two Skan ARIS Isolators equipped with integrated vaporized hydrogen peroxide decontamination technology to its microbiology laboratory in Wilmington.
AAIPharma expects both facilities to be fully validated and granted EU approval in the second quarter of 2007.