ISO 15378:2006

Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)

Publication date: 1 mar 2006

95.99 Withdrawal of Standard 25 tet 2011

General information

Current stage: 95.99 Effective date: 25 tet 2011

Originator: ISO

Owner: ISO/TC 76

Type: International Standard

ICS: 03.100.70 11.040.01

Gjuha: anglisht frëngjisht

Buying

Statusi: Shfuqizuar

PDF - 7 350 Lekë

Paper - 7 350 Lekë

CD - 7 350 Lekë

Language

Language in which you want to receive the document.

Scope

ISO 15378:2006 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 15378:2006 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

NOW

WITHDRAWN
ISO 15378:2006
95.99 Withdrawal of Standard
25 tet 2011

REVISED BY

WITHDRAWN
ISO 15378:2011

National adoptions

SSH ISO 15378:2007

DPS

Materiale të ambalazhimit të parë për produktet mjeksore - Kërkesa të veçanta për zbatimin e ISO 9001:2000, duke iu referuar praktikës së prodhimit të produktit (GMP)

95.99 Withdrawal of Standard

DPS/KT 1 më tepër