DNS/ISO 15378: 2017

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, IDT)


Status: Public comments
Start date: 20240718
End date: 20240916

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


Read draft and comment

Only informative data of projects are publicly available. To read draft and comment you will need to create account. If you are a member, please log in to your account by clicking on the "Login" button.


Login - or - Register