HollisterStier, Draxis Pharma Successfully Complete cGMP Audits

Jubilant Organosys’ two contract manufacturing facilities in North America have successfully completed regulatory cGMP audits. HollisterStier Contract Manufacturing, based in Spokane, WA, completed a successful audit by the Japanese Pharmaceutical and Medical Device Agency (PMDA) for the review of a sterile injectable product for a client.Also, Montreal–based Draxis Pharma, successfully completed an audit by the FDA and Health Canada.

The PMDA revealed no significant observations, resulting in a recommendation to the MHLW that HollisterStier be listed as an approved manufacturing site for the client’s product. That facility was also recently approved by the European Medicines Agency (EMA) as a manufacturing site for this same product.

The FDA audit of Draxis Pharma included a comprehensive cGMP review of both sterile parenteral and non-sterile semi-solid manufacturing capabilities and a Pre-Approval Inspection for three client products. No observations were received from this audit. Recommendations for site approvals for the three new client products are expected. The audit of Draxis Pharma by Health Canada focused on a cGMP review of a dedicated packaging capability and revealed no significant audit observations.

Marcelo Morales, chief executive officer of both groups, said, “We are extremely pleased with the audit findings at both our HollisterStier and Draxis Pharma facilities.Maintaining a rigorous quality culture and robust quality systems, combined with effectively managing our clients’ projects, assures the success of these projects in the global market place.”

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