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Webs sobre Normativas y Entidades |
Enlace Web |
Descripción |
Good Automated Manufacturing Practices v.5 (ISPE.ORG) GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems |
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Normativa Registro y Firma Electrónica 21 CFR Part 11 - Final Rule |
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FDA Warning Letters page (USA) |
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Food & Drug Administration (USA) - Glossary of Computer Systems Software Development Terminology (8/95) |
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Food & Drug Administration (USA) |
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ICH Q10 - Pharmaceutical Quality Systems (from ICH.ORG) |
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Final Concept Paper, ICH Q10 - Pharmaceutical Quality Systems, dated 9 September 2005, Endorsed by the ICH SC on 10 November 2005 (from ICH.ORG) |
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Agencia Española de Medicamentos y Productos Sanitarios - Inspección de Normas de Correcta Fabricación |
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Department of Health (United Kingdom) |
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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use |
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EUROPEAN MEDECINES AGENCY |
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EUROPEAN MEDECINES AGENCY ( ICH Q10 - Pharmaceutical Quality Systems ) |
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EUROPEAN MEDECINES AGENCY ( ICH Q9 - Quality Risk Management ) |
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Sociedad Española de Informática de la Salud |
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EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines. |
GAMP® 5