Today Austrianova announced that its facility in Bangkok, Thailand has been independently assessed and deemed to be ready to manufacture biologic products under current Good Manufacturing Practice (GMP). Assessment of the facility was performed by Chamow & Associates, a U.S. based expert biopharmaceutical consulting company, working on behalf of Austrianova’s partner PharmaCyte Biotech Inc.
The process began with a site visit and audit of Austrianova’s facility in Bangkok, Thailand at the end of last year, which was followed by an in-depth evaluation of key documents such as the quality management system manual and key facility related standard operating procedures (SOPs) for compliance with US-FDA requirements for GMP pharmaceutical production facilities. In addition, the Installation Qualifications (IQ) and Operational Qualifications (OQ) of all facility related equipment was found to have been completed during the assessment process.
More information and an official PR is available on our website.