Medicinal Products Packaging QMS
Applies ISO 9001 requirements to primary packaging materials for medicinal products, incorporating Good Manufacturing Practice (GMP) principles for packaging manufacturers.
ISO 15378 applies ISO 9001 requirements to manufacturers of primary packaging materials for medicinal products, integrating Good Manufacturing Practice (GMP) principles throughout. It bridges the pharmaceutical regulatory requirements and management system standards, supporting compliance with EU GMP Annex 11, ICH guidelines, and FDA regulations.
Primary packaging materials — including blister packs, vials, ampoules, and closures — come into direct contact with medicinal products, making quality and contamination control critical. The standard addresses these specific risks within a formal QMS framework.
ACI-certified auditors develop competency in evaluating packaging manufacturer QMS against both ISO and pharmaceutical GMP requirements.
Attend an ACI-Approved Training Provider (ATP) course for your chosen grade level. ACI-approved courses are aligned to the examination syllabus for ISO 15378.
Examinations are administered exclusively through ACI Approved Training Providers. Foundation and Internal Auditor examinations require 70% to pass; Lead Auditor requires 65%.
Submit your application through the ACI portal with your examination result, training certificate, and relevant audit experience log. Upon approval you receive your ACI Card ID and digital certificate.
Available Grades for ISO 15378
All six ACI auditor grades are available for this scheme. Each grade has defined competence, experience, and examination requirements.
Entry-level certification for those beginning their auditing career. Suitable for individuals who have completed foundation training but have limited audit experience.
For auditors who have completed Internal Auditor training and have begun accumulating audit experience under supervision or in an internal audit role.
Full auditor grade for practitioners with demonstrated audit experience. Recognised as a competent independent auditor of management systems.
Senior grade for experienced auditors capable of leading audit teams and managing full audit programmes. The most widely recognised auditor grade internationally.
Advanced grade for highly experienced auditors demonstrating sustained performance in complex audit environments and contributions to the auditing profession.
The highest ACI designation, awarded to individuals who have made an exceptional contribution to the management system auditing profession and to the ACI community.
Find an Approved Training Provider, sit the examination, and submit your application to ACI.