DIN EN ISO 15378:2018 Edition

$61.10

Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)

Published By	Publication Date	Number of Pages
DIN	2018-04	96

Guaranteed Safe Checkout

Categories: 03.120.10 - Quality management and quality assurance, 11.040.01 - Medical equipment in general, 11.120.10 - Medicaments, 55.040 - Packaging materials and accessories, DIN

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

Description

This 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. This standard is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.

Additional information

Published Code	DIN
Published By	Deutsches Institut für Normung
Publication Date	2018-04
Pages Count	96
Language	Germany
Descriptors	Accident prevention, Definitions, Drugs, Expendable packings, Industrial process measurement, Lock-up, Management systems, Manufacturing, Medical devices, Medical products, Medicaments, Non-reclosable, Packages, Packaging, PDCA, Pharmaceutic packages, Pharmacy, Plan-Do-Check-Act, Production, Production techniques, Purchasing, Qualification tests, Quality, Quality assurance, Quality management, Quality requirements, Risk management, Safety, Safety requirements, Specification (approval), Surveillance (approval), Testing, Testing conditions, Training, Validation, Verification, Medicine
File Size	2.4 MB
ICS Codes	03.120.10 - Quality management and quality assurance 11.040.01 - Medical equipment in general 11.120.10 - Medicaments 55.040 - Packaging materials and accessories

Preview PDF


PDF Format	Searchable	Printable	Preview Now

DIN EN ISO 15378:2018 Edition

Related products