Bioworkshops has been audited by the Jiangsu Provincial Drug Administration, the regional authority of the China NMPA, and received a Drug Manufacturing License. This milestone was achieved after Bioworkshops successfully completed the production and delivery of GMP drug substance and drug products for two monoclonal antibody projects (4x500L and 3x200L) during the preceding 5 months. Approval confirms that the Bioworkshops quality system, hardware, and operating systems are fully compliant with China NMPA cGMP standards for commercial drug production.
From July 1, 2020, authority for issue of Drug Manufacturing Licenses was transferred from the city-level to the provincial level agencies of the China National Medical Product Administration as part of their latest revision of national regulations and standards. Bioworkshops successfully passed a 2-day on-site inspection by the GMP Inspection Team from the Jiangsu Provincial Drug Administration. The scope of inspection included personnel qualifications, quality management system, production workshops, analytical laboratories, utilities, and all related records. The inspection extended from cell bank preparation to aseptic preparation of drug product.
With ICH Q10 risk-based quality management as the conceptual framework, Bioworkshops quality system meets NMPA, US-FDA, and EMA's cGMP requirements and assures the safety and effectiveness of all products. It covers the production, testing, release, and transportation of investigational medicinal products, including process transfer, method transfer/validation GMP production, product release of clinical samples, and delivery of clinical samples. Additionally, the company’s quality system covers the development and production of the preliminary engineering batch/toxicology batches, to ensure the integrity, authenticity, and traceability of the data of our services to customer requirements.
Bioworkshops has more than 700 effective SOPs, completed qualification of GMP drug substance and drug product facilities and equipment, and performed aseptic process simulation validation for multiple primary packaging material specifications. These practice meet international regulatory requirements and industry norms to ensure the quality and safety of products manufactures for our customers. With the solid foundation of quality and compliance with international regulations, Bioworkshops shorten the drug development cycle to assist clients push mew medicines to the clinical or approval stage effectively.
Dr. Simon Kwong, CEO of Bioworkshops, said :”We would like to thank the experts of the inspection team for their guidance to Bioworkshops. We attach great importance to every quality audit. Bioworkshops has consistently served its global customers with high standards of quality and high efficiency. We will continue to optimize our services in the future to be the 'new engine' for the rapidly developing biologic drug industry.”