Oktal Pharma d.o.o.

MANUFACTURING – SECONDARY PACKING

MANUFACTURING – SECONDARY PACKING

Oktal Pharma performs manufacturing operations that comply with the principles and guidelines of Good Manufacturing Practice. Certificate of GMP compliance of a manufacturer is available in EudraGMDP database, at the European Medicines Agency. 

Oktal Pharma is the first wholesaler in Croatia to receive certificates for implementation of business procedures according to new national and EU legislation within the given time frame (May 2014): Certificate of GMP compliance of a manufacturer and Certificate of GDP Compliance of a Wholesale Distributor, as evidence that it complies with the principles and guidelines of GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice). 

The Certificate of GMP compliance of a manufacturer is valid for the areas of:

• Secondary packing – manual packing of medicinal product/investigational medicinal product in an outer packaging material
• Secondary packing – manual packing of medicinal product after importation
• Batch certification
• Batch certification of imported medicinal products
• Importation of intermediate which undergoes further processing,  which refers to manual secondary packing of the imported medicinal products/investigational medicinal products