The Pre-Approval Inspection is conducted by the FDA before granting a company permission to market a new drug in the United States. This inspection of the manufacturing facility, process and quality is a critical confirmation of the ability of the manufacturer to produce a safe medicine for the public. Unfortunately, many start-ups and even established companies have difficulties during these inspections for reasons completely unrelated to their capabilities. Cleanroom Management Associates and the Microbiology Network announced today the launch of a Contamination Control Consortium to provide a comprehensive review and audit services to assist manufacturers of Pharmaceuticals, Bio-tech, OTC, Medical devices and Nanotechnology related companies to 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, the Microbiology Network. "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. This is done by only having one client at a time and devoting the team effort exclusively to that facility."
This team is dedicated to reviewing all production and support facilities and utilities, validation, testing, contamination control processes and all finished product documentation. This expert comprehensive review balances the time on-site, report of findings, and if needed, corrective action SOLUTIONS that will assist the client in a successful inspection. This cost-effective direct approach assures our clients of the best recommendations for achieving a successful inspection.
"Many companies are utilizing 'virtual services' as a strategy, this offers unique challenges to the inspection," according to Anne Marie Dixon, President of Cleanroom Management. "Between the traditional and 'virtual' inspection assistance, we estimate the annual market potential for this business to be approximately $200 million. This consortium of experts will not be able to cover this completely, but 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."
Additional information about this consortium, the participants and the services is available at http://www.microbiol.org/consulting-services/pai-preparation/ (http://www.microbiol.org/consulting-services/pai-preparation/) .