There
are significant benefits in certification to the ISO 15378 primary packaging
for medicinal products standard. It helps reduce or eliminate multiple
assessments with the additional benefits of reduction in disruption to the
business associated paperwork and costs. Additional benefits include:
- Demonstration of quality,
good manufacturing and safety controls: The ISO 15378 standard testifies to the
achievement of the principles of Good Manufacturing Practices and the
control of primary packaging items within organizations; very important
for the safety of a patient using the drug given its direct contact with
the product. The application of Good Manufacturing Practices for pharmaceutical
packaging products should ensure that they meet the needs and requirements
of the pharmaceutical industry.
- Alignment with ISO 9001:2015
specific to medicinal product packaging: This International Standard is an
application standard for primary packaging articles that contains the full
text of ISO 9001:2015, which allows certified organizations to optimize
the implementation of the requirements of ISO 9001 for the manufacture of
primary packaging materials for medicinal products
- Brand Protection: Independent ISO 15378
certification helps assure your organization’s commitment to quality and
safety, helping to improve and protect your brand and organizational
image, both publicly and with key stakeholders
- Risk management: ISO 15378
certification is designed to help organizations identify, control and
manage risks throughout the ISO 15378 audit process
- Regulatory compliance: ISO 15378
certification supports your organization’s efforts to maintain current and
anticipated future compliance with applicable statutory and regulatory
requirements
- Customer satisfaction: ISO 15378
certification is designed to help enhance customer satisfaction through
the effective application of the QMS, including processes for continual
improvement and assurance of conformity to customer requirements
User questions & answers