DIN EN ISO 15378:2016-03 PLEASE NOTE: DOCUMENT WITHDRAWN
Title (German) Primärpackmittel für Arzneimittel - Besondere Anforderungen für die Anwendung von ISO 9001:2008 entsprechend der Guten Herstellungspraxis (GMP) (ISO 15378:2015); Deutsche Fassung EN ISO 15378:2015
About this standard
This standard identifies Good Manufacturing Practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products. The realization of GMP principles in production and control of primary packaging materials within organizations is of great importance for the safety of a patient using the medicinal product, because of their direct product contact. The application of GMP for pharmaceutical packaging materials helps ensure that these materials meet the needs and requirements of the pharmaceutical industry.
The standard is an application standard which contains the normative text of ISO 9001:2008, with those clauses that are quoted directly and unchanged from ISO 9001:2008 being given in boxed text while texts in italics contain additional relevant GMP information regarding primary packaging materials.
What has changed?
This edition replaces the previous edition from February 2012, which has been technically revised to include requirements on risk management and replace the former guidance on risk management by references to relevant standards and guidelines,
- extensively revise the guidance on verification,
- qualification and validation requirements for primary packaging materials,
- and amend the requirements on infrastructure, work environment, maintenance and cleaning activities, customer communication, control of production and service provision and batch release.
Title (English) Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015); German version EN ISO 15378:2015
Document type: Standard
Publication date: 2016-03
Original language German
Document: Referenced in