¿Qué aspectos deben tenerse en cuenta mientras se fabrica bajo las BPFa?

Las pautas de la BPFa se aplican a los siguientes aspectos de la fabricación:

Proceso de producción y su control
Documentación
Edificios e instalaciones
Control de materias primas
Almacenamiento
Equipo
Laboratorio
Organización y personal

Mantente actualizado con nuestros boletines informativos.

Recibe actualizaciones oportunas sobre tus temas favoritos de parte de los expertos de Beckman Coulter Life Sciences. Ingresa tu correo electrónico.

© 2000-2025 Beckman Coulter, Inc. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. All other trademarks are the property of their respective owners.

NOT ALL PRODUCTS ARE AVAILABLE IN ALL COUNTRIES. PRODUCT AVAILABILITY AND REGULATORY STATUS DEPENDS ON COUNTRY REGISTRATION PER APPLICABLE REGULATIONS The listed regulatory status for products correspond to one of the below: IVD: In Vitro Diagnostic Products. These products are labeled "For In Vitro Diagnostic Use." ASR: Analyte Specific Reagents. These reagents are labeled "Analyte Specific Reagents. Analytical and performance characteristics are not established." CE: Products intended for in vitro diagnostic use and conforming to European Directive (98/79/EC). (Note: Devices may be CE marked to other directives than (98/79/EC) RUO: Research Use Only. These products are labeled "For Research Use Only. Not for use in diagnostic procedures." LUO: Laboratory Use Only. These products are labeled "For Laboratory Use Only." No Regulatory Status: Non-Medical Device or non-regulated articles. Not for use in diagnostic or therapeutic procedures.