Danson Pharma

Task
Task
Validation of a computerized system based on 1C,
Validation of the warehouse,
Validation of the freezer, thermal container, and cold chain,
Validation of the online climate monitoring system for the warehouse,
Development of Standard Operating Procedures
Task
Solution
Successfully completed:
- validation of the computerized system based on 1C,
- validation of warehouse areas,
- validation of the freezer, thermal container, and cold chain,
- validation of the online climate monitoring system for warehouse areas,
- the package of Standard Operating Procedures for QMS was developed

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

Qualification of ethylene oxide sterilizer

Task
Solution

Qualification was conducted

Qualification was conducted


LLC NPF Mikrokhim, Ukraine

Task
Task

Qualification of steam sterilizer

Qualification of PW

Task
Solution

Qualifications were 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