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news.JHP Pharmaceuticals' sterile manufacturing site based in Rochester, Michigan, has completed a successful GMP (Good Manufacturing Practices)/Pre Approval Audit by the FDA drug division (CDER).
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JHP Pharma is a specialty pharmaceutical company that manufactures and sells sterile injectable products for the hospital market segment, and provides contract manufacturing of sterile injectable products for innovator pharmaceutical and biotech organisations.
JHP Pharma said that this audit followed two successful GMP audits in 2009 including an audit by the FDA biologics division (CBER) and an audit by the European Medicines Agency (EMEA), which resulted in a continuance of the certificate of GMP compliance for the manufacturing site.
Stuart Hinchen, co-founder and president of JHP Pharma, said: “We are extremely pleased with the results of the recent audits of our Rochester, Michigan sterile injectable manufacturing facility. We understand the importance of compliant quality systems and we work diligently to maintain these systems to the highest global standards.”