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Validación de equipos e instalaciones

Equipos e instalaciones sin problemas

SEV ofrece sus servicios de validación de equipos e instalaciones para aquellas empresas farmacéuticas, biotecnológicas, cosméticas, veterinarias y de equipos medicinales que necesiten soporte en temas de cumplimiento con las normativas específicas del sector.
Ofrecemos un completo abanico de servicios de validación, que incluyen, entre otros:

  1. Validación de sistemas HVAC
  2. Validación de instalaciones de agua purificada y agua para inyectables
  3. Validación de instalaciones de vapor limpio
  4. Validación de instalaciones de gases medicinales (aire comprimido, nitrógeno, argón...)
  5. Cualificaciones de equipos de proceso (reactores, secadores, recubridoras, filtros…)
  6. Cualificación de líneas de acondicionamiento (primario y secundario)
  7. Validaciones de limpiezas
  8. Validaciones de procesos


Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.

21 CFR Part 211, Sec 211.63

Validation should be considered as part of the complete life cycle of a computer system. This cycle includes the stages of planning, specification, programming, testing, commissioning, documentation, operation, monitoring and modifying.

EU GMP, Annex 11, Computerized Systems

The manufacturer shall establish and implement an effective pharmaceutical quality assurance system, involving the active participation of the management and personnel of the different departments.


It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant changes to the facilities, the equipment and the processes, which may affect the quality of the product, should be validated. A risk assessment approach should be used to determine the scope and extent of validation.

EU GMP, Annex 15, Qualification and validation