BS EN ISO 15378:2011 - Page 2

Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP). | Status: Revised, Superseded, Withdrawn

1 Scope

1.1 General

This International 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. In this International Standard 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. ISO 9001:2008 , Quality management systems — Requirements 1.1 General This International Standard specifies requirements for a quality management system where an organization

1. a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
2. b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

NOTE 1 In this International Standard, the term “product” only applies to

1. a) product intended for, or required by, a customer,
2. b) any intended output resulting from the product realization processes.

NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.