-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:
Pharmaceutical industry, chemical production process, different systems and production equipment.
Critical systems equipment (Purify Water PW/WFI, HVAC CIP, clean rooms, protected areas and stability cabinets).
Microbiological methods, environmental & hygienic microbiological control program.
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).