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On Tuesday the 13th June 2006, the U.S. Food and Drug Administration (FDA) started an intensive three day Good Manufacturing Practice (GMP) audit on Aesica's Cramlington site. The basis of the audit was to determine whether the site's policies and practices met the high standards demanded by the U.S. government for the import of pharmaceutical active ingredients into their country.
The audit covered all aspects of manufacture of Paroxetine Hydrochloride, including plant condition, batch records, analytical records, non-conformance reporting and change management. At the end of the inspection, Aesica were given no corrective actions and as such were not issued with a form 483, which is an excellent performance.
Chris Gowland, Aesica's Compliance Director, commented that "The inspectors checked the records in the finest detail including calculation accuracy, work logs, materials buy off, reconciliations and labeling and found a large degree of accuracy. As a result I believe that this is now the new benchmark for the site and that every endeavour will be made to ensure that this level of compliance, in all future activities, is maintained. The success of the audit was down to the hard work and high standards of our staff. This excellent result, in addition to the MHRA accreditation gained in October 2005, and will continue to help Aesica Pharmaceuticals attract new business to the site."
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