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.”