IsO 15378:2017(E) Primary packaging materials for medicinal products —Particular requirements for the application of Iso 9001:2015, with reference to good manufacturingpractice (GMP)
1 Scope
lso 9001:2015,Quality management systems - Requirements1 Scope
This International Standard specifies requirements for a quality management system when anorganization:
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 andapplicable statutory and regulatory requirements.
All the requirements of this International Standard are generic and are intended to be applicable toany 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 servicesintended for, or required by, a customer.
NOTE2 Statutory and regulatory requirements can be expressed as legal requirements.
ln addition to lSo 9001, this document specifies Good Manufacturing Practice (GMP) requirementsapplicable to primary packaging materials for a quality management system where an organizationneeds to demonstrate its ability to provide primary packaging materials for medicinal products,which consistently meet customer requirements, including regulatory requirements and InternationalStandards.
ln this document the term "if appropriate" is used several times. When a requirement is qualified by thisphrase, 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 packagingmaterials for medicinal products.

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