We Ensure Best Service
ISO 15378:2017 was developed by pharmaceutical industry stakeholders to offer a Good Manufacturing Practices (GMP) for manufacturers and suppliers of primary packaging material for medicinal products.
This document, in addition to ISO 9001, specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system in which an organization must demonstrate its ability to provide primary packaging materials for medicinal products that consistently meet customer requirements, including regulatory requirements and International Standards.
Your Benefits at A Glance
- Evidence of adherence to legal requirements and contractual obligations
- Reduction and control of risks.
- Clear statement of the organization’s competence.
- Improves quality capability.
- Enhancement in processes.
- Minimization or removal of instances of contamination.
- Assures implementation of GMP Principals.
- Minimise risk by achieving documented compliance with safety standards, thereby avoiding costly liability.
- Gain a competitive edge by demonstrating the ISO 15378 compliance of your organization to all stakeholders with a trusted third-party certification partner.
- Profit from an expert partnership with the guidance of our highly skilled experts in pharmaceutical packaging services.
Clients Testimonials
We engaged Echelon Consultancy because we wanted to build a robust and effective management system within our organization.
“Echelon Consultancy is engaged with us since 2011, they have wonderfully helped us to integrate our management systems, trained our people and help build a positive culture within the organization”
“We began working with Echelon Consultancy because we wanted to implement Integrated Management Systems effectively and efficiently”
“We had appointed Echelon Consultancy in the year 2015 as we were facing lots of challenges in managing our processes. They have not only helped us in solving those challenges, but also help build a positive culture within the organization.”
- ISO 9001:2015 – Quality Management Systems
- ISO 14001:2015 – Environment Management Systems
- ISO 45001:2018 – Occupational Health and Safety Management Systems
- ISO 22000:2018 – Food Safety Management Systems
- ISO 15378:2017 – Primary Packaging Materials for Medicinal Products
- ISO 13485:2016 – Medical Devices Quality Management Systems
- ISO 22301 – Business Continuity Management System Certification
- ISO 22716:2007: COSMETICS — GOOD MANUFACTURING PRACTICES (GMP)
- ISO 50001 – Energy Management Systems
- SEDEX – Supplier Ethical Data Exchange
- SMETA – SEDEX Members Ethical Trade Audit
- FSSC 22000 – Foundation Food Safety System Certification
- BRC – British Retail Consortium