Production

GOOD MANUFACTURING PRACTICE /GMP/, as regards pharmaceuticals, is a system of QUALITY ASSURANCE, guaranteeing that the pharmaceuticals are being produced, stored and regularly controlled in compliance with the regulatory standards.

RAMCOPHARM’s factory has, as provided for in the principles of the GOOD MANUFACTURING PRACTICE, initiated all organizational measures, secured all temperature and hygiene conditions and observed all requirements guaranteeing that the produced pharmaceutical product possesses the qualities needed for its designation. The food additives of RAMCOPHARM LTD are produced in conditions appropriate for pharmaceuticals’ manufacture:

         •Production facilities are ranked D class of cleanness secured by:

             ■Air conditioning installation, equipped with highly effective HEPA filters; 
             ■Special wall panels, ceiling and floor covering allowing for fast and easy cleaning and disinfection made with the help of up-to-date methods. Apart from the specialized products we also use water purified through ion-exchange resin and UV irradiation;

         •Each work process (from the conduct of our staff members in the cleaned premises to the discarding of the production waste, from the control over the raw materials to the sale of the final product) is regulated through STANDARD OPERATIVE PROCEDURE, affirmed by the Manager, of full force and effect as regards each participant in the relevant process.
        •Each product batch has its Batch Record – precise information on the activities involved in the production process. This allows, at any time, to trace/observe:

              ■The quality of the raw materials,
              ■The results of the analyses of the intermediate products upon conclusion of each production stage,
              ■Process conditions,
              ■The employee performing the process and the controlling employee, 
              ■The results of the final product analysis and the buyer.