The purpose of the audit was to confirm that CMAB's quality standards are in line with European GMP, thereby verifying that its quality assurance and control systems can meet the requirements of development, production and testing of biologics for use as clinical investigational medicinal products (IMP) in Europe. The auditors conducted a comprehensive and thorough inspection of the company's quality systems, production and warehousing facilities, utilities and QC laboratory during the two day inspection, and gave a high appraisal of CMAB.
As noted in the official report, "CMAB was observed to be a company with solid and sound business practices and quality focused goals and objectives. The commitment to quality and their business partners is clear and documented into all their system processes. The structure of their Quality Management System and the management commitment to quality is visible at all processes. The facilities were maintained, organized and functional and the company has knowledgeable and well trained staff."
In addition, the report concluded that, "A comprehensive corporate Quality Management System based on the principles of GMP was in place. CMAB's premises and equipment were suitable and adequate to ensure proper manufacturing, storage, distribution as well as return and destruction activities of medicinal products used in clinical trials. Therefore, the overall impression of CMAB was positive and thus the drug manufacture and associated processes were considered GMP compliant and suitable for Parexel International Co.
Also, CMAB was in compliance with EU Eudralex Volume 4 GMP for Medicinal Products for Human and Veterinary Use and fulfill the requirements for IMP EU import."
"This result confirms our obligation to international partners and provides externally validated assurance that we conform to all the necessary infrastructure and policies in relation to the quality manufacturing of biologic products,” said Dr. Yongzhong Wang, chief executive officer, CMAB Biopharma. “I am immensely proud of the work and diligence that has gone into this review by our excellent quality team within CMAB, and indeed the wider organization, as we pass another milestone in our evolution towards being a fully integrated international CDMO."
Michael Frizberg, president, CMAB Biopharma International, said, "Since founding CMAB Biopharma in July 2017, we have been entirely focused on meeting the stringent requirements of international biologics production and supply, so today's positive opinion is an incredibly important step in our brief history and we look forward to building more international partnerships."