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Certification according to EN ISO 15378:2006
The primary packaging materials standard DIN EN ISO 15378:2007 was specifically developed for the manufacturers of packaging materials for pharmaceutical products. It is based on the internationally recognised standard ISO 9001:2000. Inspire trust as a manufacturer with an internationally recognised certification.
This standard defines quality management system (QMS) requirements for the
- design/development
- production
- customer services and
- assembly
of primary packaging materials for pharmaceutical products.
It covers all GMP (Good Manufacturing Practice) principles that apply to the manufacturing of primary packaging materials. In addition to the requirements of ISO 9001:2000, a series of additional criteria specifically relating to the packaging industry must be fulfilled for DIN EN ISO 15378:2007.
These include, for example:
- Batch tracing
- Controlled environmental conditions
- Validation
- Risk management
Four steps to success
- Pre-audit
Consultation and preliminary assessment by means of a site visit. - Document review
Quality management documents are checked to confirm that they fulfil the requirements of the standard. - Certification audit
The practical use of your quality management system is inspected and evaluated for effectiveness and a report is drawn up. - Issue of certificate
Certification is carried out when all criteria are met. The quality management system is certified as being effective and compliant with the standard.
The TÜV Rheinland Group is the first technical inspection organisation to be accredited as an international certification body by the TGA (German Association for Accreditation).
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