GMPhar Consultants for the Industry
Pharmaceutical, Medical Devices
Cosmetic and Food




normas GMP&L

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La Importancia de la Validacion

Microbiológica en los Sistemas de

Agua Purificada 

Por la Dra. Nora Rabinovich

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Address: Gualeguaychu 1718/20 (C1407ALL) Ciudad Autónoma de Buenos Aires - Argentina. Tel.:+54(11)4566-4968/4504-5641

-GMPhar Consultants for the Industry Water System PW/WFI-

All high purity water systems are designed in accordance with the latest FDA, USP & EP regulations. They are fully coordinated with the QA & QC departments with regards to all relevant production processes, requirements and system classifications relating to bacterial, pH, TOC, conductivity levels or any other desired specifications.

  • Establishment of a URS. User Requirement Specification (a detailed set of specifications against which each system could be sourced and qualified against).
  • Design, preparation of system’s drawings, block diagram, major components diagram, detailed P&ID, detailed layout of major equipment, isometric drawings.
  • Preparation: schedule of operation for each component and PLC parameters of control for the whole system.
  • Validation of each piping element, including all welding numbers, Our firm offers a complete system Validation Program, based on special requirements specified by the facility QA department, including:
    • Performing tests and daily check lists of all critical instrumentation parameters.
    • Daily routine sampling of required use-points (chemical/ microbiological) according to PQ plan.
    • Biofilms treatment

    Alliance Partners GAMA-SEPTIC Ltd.