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Construction Work For Manufacturing Plant – Design And Construction Of A Plant For The Production Of Medicines From Human Plasma. The Subject Of This Procurement Is The Design, I.E. The Creation Of The Conceptual Project, The Main And Executive Project, The Construction, Equipping, Qualification And Validation Of A Plant For The Production Of Medicines From Human Blood Plasma In Accordance With The Relevant Legal Regulations And Regulations Of Good Practices (Gxp), The Technology For The Production Of Medicines From Human Blood Plasma , Transfer Of Knowledge And Technology, Testing Of The Production Process, Obtaining All Necessary Permits And Approvals For Placing Drugs On The Market, Starting Production, Consulting, Support And Maintenance (Within The Appropriate Warranty Period), According To The Turnkey Principle And The Design And Build Model . The Project Should Include All Necessary Thermotechnical Installations, Including External Infrastructure Related To Connections To Traffic And Other Necessary Infrastructure And All Other Infrastructural And Other Facilities Necessary For The Complete Functioning Of The Plant. The Basic Medicines From Human Plasma, The Production Of Which Is Planned To Be Established In The Plant, Are Albumin, Normal Immunoglobulins And Coagulation Factors (Fviii And Fix). The Capacity Of The Facility, Measured By The Annual Amount Of Human Blood Plasma That Must Be Able To Be Processed Into Medicines, Is 100,000 Liters. Plasma Fractionation Technology, Ie Isolation Of Intermediates For The Production Of Albumin And Immunoglobulin (Crude Fractions Of Precipitated Individual Proteins) Must Be Based On Precipitation With Ethanol In A Cold, Preferably Kistler-Nitschman Procedure. The Land On Which The Construction Of The Plant Is Planned Bears The Designation Kč. No. 254/13 K.O. Rugvica In The Municipality Of Rugvica And Is Located In The Working Zone Of Rugvica - North. A Space Of 70 M X 35 M X 12 M (Length X Width X Height) Is Available For The Plant Building. The Production Process, Design, Construction, Commissioning Of The Plant And Production In The Built Plant Must Fully Follow Good Manufacturing Practice (Dpp, English Gmp - Good Manufacturing Practice). Manufactured Medicines Must Meet The Requirements Of The Approval For Placing On The Market, Must Be Suitable For The Intended Use And Must Be Of Appropriate Harmlessness, Quality And Effectiveness, For Which Purpose It Is Necessary To Establish And Apply Appropriate Production And Quality Control Procedures In Accordance With The Requirements Of The Dpp And The European Pharmacopoeia And Conditions Appropriate Production Permits, Whereby Verification Is The Responsibility Of The Croatian Agency For Medicines And Medical Products (Halmed), Which Is Also Responsible For Issuing Production Permits And Approvals For Placing Medicines On The Market. Accordingly, The Requirements For The Design And Construction Of The Plant Are Determined By The Production Process And Dpp Conditions Related To The Production Of Medicines From Human Plasma, While The Requirements For The Design And Construction Of The Plant Building Are Determined By The Needs Of The Plant And Production. The Construction Of A Special Building With A Biotechnological Facility For Carrying Out The Complete Production Process Is Planned. The Plant Should Be Ex
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