Scientific and Manufacturing Company Ekopharm LTD

Task
Task

Conceptual design

Detailed design (3D design)

Project plan development

Performing general contractor functions

Qualification of all production equipment, laboratory instruments and warehouses

Processes validation and cleaning validation

Task
Solution

Conceptual and detailed design was developed

The project plan was developed

The qualification of all production equipment, laboratory instruments and warehouses was performed

The processes validation and cleaning validation were performed

Manufacturing License was obtained

GMP certificate was obtained


Medfarcom-Center, Kiev, Ukraine

Task
Task
Validation of the computer enterprise management system Microsoft Dynamics AX
Task
Solution

Validation of the Microsoft Dynamics AX was conducted


Republican Unitary Production Enterprise Belmedpreparaty, Minsk, Belarus

Task
Task

05.2017

    Qualification of steam sterilizers Fluipharm 9 6 18-2H R, Steam Sterilizer STERIVAP HP IL

    Pure steam quality testing

07.2017

    Qualification of steam sterilizers Unisteri HP IL.

    Pure steam quality testing

Task
Solution

Qualifications were conducted


Experimental Production Center Olimp, Vyshneve, Ukraine

Task
Task

Qualification of the clean rooms and laminars

Task
Solution

Qualification was conducted


Experimental Production Center Olimp, Vyshneve, Ukraine

Task
Task

Qualification of ethylene oxide sterilizer

Task
Solution

Qualification was conducted


İmaretcioglu Limited, Samsun, Turkey

Task
Task

Qualification of a computerized system for Shimadzu HPLC

Qualification of the ampoule filling machine

Qualification of ampoules filling machine

GMP Audits

Support in GMP certification

Task
Solution

Qualifications were performed

Based on recommendations from consultants, many processes have been improved

GMP Compliance Certificate was obtained

GMP Certificate issued by the State Medicines Service of Ukraine was recognized by the Canadian Regulatory Authority


Republican Unitary Production Enterprise Belmedpreparaty, Minsk, Belarus

Task
Task

09.2016

  Qualification of steam sterilizer STERIVAP HP IL

02.2017

  Qualification of steam sterilizer Steam Sterilizer STERIMAT PLUS

  Pure steam quality testing

Task
Solution

Qualifications were conducted


LLC “Immunolog”, Vinnitsa, Ukraine

Task
Task

Qualification of steam sterilizer

Qualification of a depyrogenation oven

Task
Solution

Qualifications were conducted