Bioworkshops successfully passed EU QP audit
SUZHOU, China, Jan. 6, 2021 /PRNewswire/ -- In November 2020, Bioworkshops passed a European drug Qualified Person audit (QP audit) for manufacture of clinical drug substance and drug product at their Suzhou site. The ratification of compliance to EU GMP comes within a month of obtaining a Drug Manufacturing License from the NMPA and completing the GMP manufacture and delivery of two projects. These achievements demonstrate the company's quality system can fully meet EMA, NMPA, and FDA drug regulatory requirements and are a great example of high quality "Bioworkshops speed".
In November 2020, Bioworkshops, a professional biopharmaceutical CDMO located in Suzhou Industrial Park, China, completed a three-day audit to assess its capabilities and infrastructure to adhere to European Commission Guidelines to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use ("QP Audit"). The audit was conducted by the international, independent regulatory and compliance agency ProPharma Group (www.propharmagroup.com) and evaluated both drug substance and finished product manufacturing for compliance to EudraLex Volume 4 European Union Guidelines (EU GMP). Bioworkshops successfully passed the audit for clinical production, validating that it has the capability to provide production and analytical services to customers that intend to conduct clinical trials within Europe. It also shows that Bioworkshops hardware facilities, quality system, and operations comply with the general GMP standards of the international pharmaceutical industry. As a biologics CDMO established just over a year ago, it is another great example of "Bioworkshops Speed", laying a solid foundation for growth into the global stage.
With COVID-19 travel restrictions prevailing, the audit was conducted remotely in English. At Bioworkshops all GMP procedures are bilingual for ease of audit by international agencies. The live online audit provided the auditors thorough understanding of Bioworkshops facilities and operation of the quality management system. The scope of the audit covered manufacturing and testing of Drug Substance and Drug Product for compliance with all chapters and all applicable annexes of EudraLex Volume 4 European Union Guidelines and ICH guidelines (EU GMP).
Since the completing construction of the production facility with capability of up to 6×2000L in May 2020, Bioworkshops has successfully completed two client projects with multiple batches at 500L and 200L GMP for drug substances and aseptic products for IND submissions. Bioworkshops is committed to provide efficient and economical biopharmaceutical outsourcing service and solutions for global business partners. The team has massive depth of experience in biopharmaceutical development which provides solid foundation for high-quality operations.
Dr. Simon Kwong, CEO of Bioworkshops, expressed his gratitude to the auditors for their diligence in assessing the company's quality standards. "Quality is always at the heart of serving our customers. Passing an EU QP audit within such a short period of time proves that we reliably serve our customers with global quality standards and high efficiency. Thanks to the auditors from ProPharma for their meticulous inspection and our team members for their hard work to establish the systems during this year. A big thanks to our customers for their support and recognition in selecting Bioworkshops. Bioworkshops will continue to be a "new engine" for development of the biopharmaceutical industry and continue to accelerate development of biopharmaceutical R&D and manufacture, serving our clients faster and better."
About Bioworkshops (Suzhou) Limited
Bioworkshops is a professional biologics contract development and manufacturing service provider committed to offering cost-effective and efficient outsourcing solutions to assist our customers shorten the time to start clinical trials and enter markets. Our services include process development, analytical development and cGMP manufacturing. Our Mission is working with selected global partners to achieve rapid approval of clinical and commercial biologics by applying our expertise in development and manufacturing from a base in China.
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SOURCE Bioworkshops (Suzhou) Limited
