What is ISO 15378:2017 Certification
This standard specifies particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) requirements, applicable to primary packaging materials for a quality management system (QMS) where an organization needs to demonstrate the ability to provide primary packaging materials for medicinal products that consistently meet customer and regulatory requirements as well as international best practice.
It is applicable for the design, manufacture and supply of primary packaging materials for medicinal products; the standard is generic and intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
Advantages:
• Demonstration of quality, good manufacturing and safety controls: This 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: This 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: This certification is designed to help organizations identify, control and manage risks throughout the ISO 15378 audit process
• Regulatory compliance: This certification supports your organization’s efforts to maintain current and anticipated future compliance with applicable statutory and regulatory requirements
• Customer satisfaction: This 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
Structure
Introduction
1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement
Annexure
A: Clarification of new structure, terminology and concepts
B: Other international standards on quality management and quality management system
developed by ISO/TC 176
C: GMP requirements for printed primary packaging materials
D: Guidance on verification, qualification and validation requirements for primary packaging
materials
How to get / what is Process for ISO certification?
To get the ISO certification, please fill up below given form & our team will contact you.
Step-1 Query from the Client
Step-2 Filling up the Application form
Step-3 Agreement Approval
Step-4 Stage-1 Audit
Step-5 Stage-1 Audit NC’s Closing
Step-6 Stage-2 Audit
Step-7 Stage-2 Audit NC’s Closing
Step-8 Certificate Release