ISO 15378:2017 pdf download.Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:201 5, with reference to good manufacturing practice (GMP)
1 Scope
ISO 15378 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 “products 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.
2 Normative references
ISO 9001:2015, Quality management systems — Requirements
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:20 15, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000:2015 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
-ISO Online browsing platform: available at http://www.iso.org/obp
-IEC Electropedia: available at http://www.electropedia.org/
NOTE 1 This document only duplicates terms and definitions of ISO 9000:2015 when they have been amended in order to address the specific needs of this document.
NOTE 2 The structure of terms and definitions in this document corresponds to that used in ISO 9000:2015,as far as applicable. An additional heading "Terms related to risk management" has been added in this document.
NOTE 3 An index of defined terms is found at the end of this document.ISO 15378 pdf download.