ČSN EN ISO 15378 (855290) Zrušená norma

Primární obalové materiály léčiv - Zvláštní požadavky pro aplikaci ISO 9001:2008 odpovídající správné výrobní praxi (GMP)

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Anotace obsahu normy

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.
This International Standard specifies requirements for a quality management system where an organization
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
NOTE 1: In this International Standard, the term "product" only applies to
a) product intended for, or required by, a customer,
b) any intended output resulting from the product realization processes.
NOTE 2: Statutory and regulatory requirements can be expressed as legal requirements.
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.

Označení ČSN EN ISO 15378 (855290)
Katalogové číslo 99455
Cena 590 Kč590
Datum schválení 1. 5. 2016
Datum účinnosti 1. 6. 2016
Jazyk angličtina (obsahuje pouze anglický originál)
Počet stran 80 stran formátu A4
EAN kód 8590963994550
Norma byla zrušena k 1. 6. 2018
a nahrazena ČSN EN ISO 15378 (855290)
Tato norma nahradila ČSN EN ISO 15378 (855290) z května 2012
Dostupnost skladem (tisk na počkání)