Phone: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Standards sales: prodaja@iss.rs Education: iss-edukacija@iss.rs Information about standards: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Main menu

SRPS EN ISO 15378:2015

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2011)

Sep 30, 2015
95.99   Withdrawal of Standard   Dec 25, 2017

General information

95.99     Dec 25, 2017

ISS

Z076

European Norm

03.120.10     11.040.01     03.100.70  

English  

Buying

Withdrawn

Language in which you want to receive the document.

Scope

ISO 15378:2011 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.
ISO 15378:2011 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 15378:2008

NOW

WITHDRAWN
SRPS EN ISO 15378:2015
95.99 Withdrawal of Standard
Dec 25, 2017

REVISED BY

PUBLISHED
SRPS EN ISO 15378:2017

Related project

Adopted from EN ISO 15378:2011

Adopted from ISO 15378:2011