Producidos por profesionales de la industria farmacéutica, los documentos de guía de ISPE proporcionan la información práctica y real que necesita para ayudar a su empresa a realizar las mejores prácticas, cumpliendo y superando los estándares regulatorios.

guia-de-buenas-practicas-de-ispe-en-espanol-2014-calefaccion-ventilacion-y-aire-acondicionado-hvac

Guía técnica de Calefacción, Ventilación y Aire acondicionado

1° Guía de Buenas Prácticas en Español Las Baselines Guides de ISPE ofrecen sustento técnico para realizar, operar y mantener instalaciones acorde a normativas cGMP.

Más Info
gamp2

GAMP Guide: Records & Data Integrity

The importance of ensuring data integrity is reflected in guidance, citations, and public comments of Regulators and Health Agencies. A number of companies have suffered serious regulatory and financial consequences…

Más Info
gamp5

GAMP Good Practice Guide: Electronic Data Archiving

This Guide provides a rational and scaleable approach to electronic data archiving through the development of an archiving strategy. The implementation of such a strategy should assist organizations to achieve…

Más Info
gamp4

GAMP Good Practice Guide: Computerized GCP Systems & Data

The ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data (Good eClinical Practice) is intended to provide a risk-based approach to validating diverse computerized GCP systems in…

Más Info
gamp3

GAMP Good Practice Guide: Calibration Management

The GAMP® Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition)provides guidance in setting up a calibration management system, which will give a structured approach to instrument risk assessment, calibration…

Más Info
gamp1 copia

GAMP 5 Guide: Compliant GxP Computerized Systems

GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems provides pragmatic and practical industry guidance that aims to achieve compliant computerized systems that are fit for intended use in…

Más Info