HRN EN ISO 15378:2017
Materijali za unutarnje pakiranje lijekova -- Posebni zahtjevi za primjenu norme ISO 9001:2015 u odnosu na dobru proizvođačku praksu (DPP) (GMP) (ISO 15378:2017; EN ISO 15378:2017)
| Oznaka: | HRN EN ISO 15378:2017 |
| Naslov (HR): | Materijali za unutarnje pakiranje lijekova -- Posebni zahtjevi za primjenu norme ISO 9001:2015 u odnosu na dobru proizvođačku praksu (DPP) (GMP) (ISO 15378:2017; EN ISO 15378:2017) |
| Naslov (EN): | 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; EN ISO 15378:2017) |
| Područje primjene (EN): | ISO 15378:2017 specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. NOTE 1 In this International Standard, the terms product or service only apply to products and services intended for, or required by, a customer. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials 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. In ISO 15378:2017 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. ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. |
| Izdanje: | 4 |
| ICS: | 03.120.10 Upravljanje kvalitetom i osiguravanje kvalitete 11.040.01 Medicinska oprema općenito 11.120.10 Lijekovi 55.040 Materijali i pribor za ambalažu i pakiranje |
| Tehnički odbor/pododbor: | TO 574, Sustavi upravljanja kvalitetom, rizicima, vrijednostima i inovacijama |
| Oznaka faze: | 60.60 - HRN dostupan |
| Glasilo (rasprava): | HZN e-Glasilo 5/2016 () |
| Glasilo (objava): | HZN e-Glasilo 11/2017 () |
| Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
| Cijena #1: | Cijena: 64,00 € | Jezik: en | Cjenovni razred: N | Broj stranica: 83 |
| Izvornik: | EN ISO 15378:2017 |
| Zamjenjuje: | HRN EN ISO 15378:2015 |
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