DIN EN ISO 15378:2018-04
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017); German version EN ISO 15378:2017 / Note: To be amended by DIN EN ISO 15378/A1 (2024-05).
| Fecha edición: |
2018-04-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials. |
| Keywords: | Accident prevention|Definitions|Drugs|Expendable packings|Industrial process measurement|Lock-up|Management systems|Manufacturing|Medical devices|Medical products|Medicaments|Non-reclosable|Packages|Packaging|PDCA|Pharmaceutic packages|Pharmacy|Plan-Do-Check-Act|Production|Production techniques|Purchasing|Qualification tests|Quality|Quality assurance|Quality management|Quality requirements|Risk management|Safety|Safety requirements|Specification (approval)|Surveillance (approval)|Testing|Testing conditions|Training|Validation|Verification |
| ICS: | 11.040.01 - Equipo médico en general, 03.120.10 - Gestión y aseguramiento de la calidad, 11.120.10 - Medicamentos, 55.040 - Material de embalaje y sus accesorios |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 15378:2017/A1:2024 Idéntica ISO 15378:2017/Amd 1:2024 |
|
Modificaciones Normas |
Es modificada por DIN EN ISO 15378/A1:2024-11 |
|
Reemplazo Normas |
Reemplaza a DIN EN ISO 15378:2016-03 Reemplaza a DIN EN ISO 15378:2016-11 |
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