UK ACCREDITATION FORUMISO 15378:2015 Certification
ISO 15378 combines quality-management principles with good manufacturing practice considerations for manufacturers of primary packaging materials used with medicinal products.
Main focus areas
- Quality management
- Good manufacturing practice
- Contamination control
- Traceability
- Risk management
Typical value
A structured management or technical standard can help an organization document responsibilities, control key activities, evaluate performance and improve confidence among interested parties. Certification or accreditation requirements vary by standard and scope.