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 Quality Management-

GMPhar offers consulting in local and international regulatory affaires, International Standards. Pre-Approval audits performed by the, Local Regulatory Administration Authorities, e.g. ANMAT in Argentine, FDA in USA, EC in Europe, and similar.

  • International Standards/ compliance auditing: cGMP, GLP, GCP, ISO Clean rooms. QA/QC, maintenance, cleaning in place, manufactures procedures.
  • Validation documentation DQ/IQ/OQ/PQ for:
    1. Pharmaceutical industry, chemical production process, different systems and production equipment.
    2. Critical systems equipment (Purify Water PW/WFI, HVAC CIP, clean rooms, protected areas and stability cabinets).
    3. Microbiological methods, environmental & hygienic microbiological control program.
    4. Computerized System Validation, MRP II, ERP and Training Management Systems, PLC’s, Motion Controllers, Vision Systems, SCADA Systems, Industrial PC’s , Hardware & Software. (Application of CFR 211, Part 11 and Electronic Records and Signatures Validation).