Jinan Jinda Pharmaceutical Chemistry Company contracts with ChemWerth to re-establish cGMP standards
Shandong, China based manufacturer facility seeks to overturn recent quality deficiency issued by the European Directorate of Quality Medicines (EDQM)
Woodbridge, CT, – Jinan Jinda Pharmaceutical Chemistry Company's recent EDQM inspection resulted in a suspension of their certificate of suitability RO-CEP 2011-240-Rev 01/ Nitrofurantoin. Since then, Jinda has contracted ChemWerth to provide regulatory and compliance expertise to resolve the issues they are now facing.
Cheng Yushui, General Manager of Jinan Jinda, stated, "We are pleased to announce Jinan Jinda has entered into a five year service agreement with ChemWerth with the goal being to correct Jinda's quality system and GMP compliance conditions. With ChemWerth's help, we plan to reapply for EDQM re-inspection within one year. Our commitment to be a qualified supplier for the EU and US regulatory markets has never changed." Given Jinda's desire to remedy this situation and improve the consistency of good manufacturing practices, ChemWerth's Regulatory and Compliance team have already been deployed to Jinda and are working to correct their problems.
"ChemWerth will incorporate more rigorous systems to assure the proper design, monitoring and control of the manufacturing process; including proper data integrity protocols and document management. That's the ChemWerth difference," Said Peter Werth CEO and President of ChemWerth, Inc. Werth continued, "ChemWerth Compliance Programs include our proprietary Six System +1 Audit, cGMP Seminar Series and Three Phase Factory Evaluation Program. Jinda will receive our full complement of regulatory and compliance support."
While ChemWerth works with Jinda on other projects, Nitrofurantoin was not one of ChemWerth's products. However, as Jinda's compliance agent, this now allows ChemWerth to execute the 'One World, One Quality' concept to all Jinda's products regardless of who is Jinda's sales representative.
Founded in 1982, ChemWerth is a full service generic API development and supply company. ChemWerth has expertise in manufacturing specialty API's; developing non-infringement patent strategies; and, providing world-class regulatory support. The company has manufacturing partners in China, India, Europe and the United States. For more information about the company please visit www.chemwerth.com.