Contamination Control Consortium launched
Will provide a review and audit service to assist in pre-approval and other licensing inspections
Cleanroom Management Associates and the Microbiology Network in the US have launched a Contamination Control Consortium to provide a comprehensive review and audit service to manufacturers of pharmaceuticals, as well as companies involved in bio-technology, otc medicines, medical devices and nanotechnology. It aims to help these organisations meet regulatory standards in pre-approval inspection (PAI) and other licensing inspections for US and International compliance.
“Every day delayed by an avoidable regulatory objection can mean tens or hundreds of thousands of dollars in lost sales revenues,” said Scott Sutton, principal at the Microbiology Network and a Consortium member.
“We provide proven, experienced and veteran consultants, each of whom is successful as an independent service provider, to provide an in-depth and rapid review of the facility's readiness for a regulatory inspection.”
The consortium is comprised of four experts experienced in reviewing all production and support facilities and utilities, validation, testing, contamination control processes and all finished product documentation. Their review will balance the time on-site, report of findings, and if needed, corrective actions that will assist the client in a successful inspection.
“Many companies are utilising 'virtual services' as a strategy, this offers unique challenges to the inspection,” said Anne Marie Dixon, president of Cleanroom Management and another Consortium member.
“This consortium of experts will be able to offer top-line inspection preparation and solutions to those who are interested in outside input before the audit, or high-end consultations to correct significant audit findings.”
In addition to pre-approval inspection services, the team is available for regulatory and cGMP compliant document review and preparation, audits and reviews, and due diligence audits.