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ISO 15378

Primary packaging

This standard is based on ISO 9001 (quality) and was especially developed for producers of packaging materials for pharmaceutical products. It defines standard requirements of design/development, production, after sales service and assembly for a quality management system (QMS), but also a lot of additional criteria for packaging industry such as following-up batches and its documentation, supervised ambient conditions, validation/qualification and risk management. It comprises all GMP regulations (GMP = good manufacturing practice) which are usually applied during production of packaging materials.

Update version:ISO 15378:2007