Performed as part of the Ministry of Health’s routine evaluation, the audit confirmed the facility’s compliance with IMOH GMP requirements for the manufacture of medicinal products, the importation of medicinal products and the manufacture of active substances using biological processes, Kamada said.
The compliance status granted by the audit is valid for three years. It is also valid under the provisions of the Conformity Assessment and Acceptance of Industrial Products agreement between the European Union and Israel, as the IMOH is a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme.
Kamada chief executive officer David Tsur said, "This positive audit underscores the viability, quality and high standards Kamada upholds in the manufacture of our plasma-derived therapeutic proteins both for commercial use and for products under development in compliance with international standards."