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.
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…
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.
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…
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…
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…
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…
