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DIN EN ISO 15378
English -- Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015);
German -- Primaerpackmittel fuer Arzneimittel - Besondere Anforderungen fuer die Anwendung von ISO 9001:2008 entsprechend der Guten Herstellungspraxis (GMP) (ISO 15378:2015)
Organization:
DIN - Deutsches Institut fš?r Normung e. V.
Year: 2016
Abstract: Scope: General This International 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. In this International Standard, the term “if appropriate” is used several times. When a requirement is qualified by this phrase, it is deemed to be “appropriate” unless the organization can document a justification otherwise. Application This International Standard is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.
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DIN EN ISO 15378
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| contributor author | DIN - Deutsches Institut fš?r Normung e. V. | |
| date accessioned | 2017-10-18T10:58:53Z | |
| date available | 2017-10-18T10:58:53Z | |
| date copyright | 2016.03.01 | |
| date issued | 2016 | |
| identifier other | KISZOFAAAAAAAAAA.pdf | |
| identifier uri | https://yse.yabesh.ir/std/handle/yse/233245 | |
| description abstract | Scope: General This International 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. In this International Standard, the term “if appropriate” is used several times. When a requirement is qualified by this phrase, it is deemed to be “appropriate” unless the organization can document a justification otherwise. Application This International Standard is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes. | |
| language | English | |
| title | DIN EN ISO 15378 | num |
| title | English -- Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015) | en |
| title | German -- Primaerpackmittel fuer Arzneimittel - Besondere Anforderungen fuer die Anwendung von ISO 9001:2008 entsprechend der Guten Herstellungspraxis (GMP) (ISO 15378:2015) | other |
| type | standard | |
| page | 76 | |
| status | Active | |
| tree | DIN - Deutsches Institut fš?r Normung e. V.:;2016 | |
| contenttype | fulltext |