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ISO 15378:2017
Quality Management System for Primary Packaging Materials of Medicinal Products
ISO 15378:2017 specifies requirements for a Quality Management System where an Organization needs to demonstrate its ability to provide Primary Packaging Materials for Medicinal Products, which consistently meet Customer Requirements, including Regulatory Requirements and International Standards. The ISO 15378:2017 – Primary Packaging Materials for Medicinal products was developed by stakeholders in the pharmaceutical sector to provide a Quality Management System (QMS) for suppliers of materials intended to be used as packaging for medicinal products. Published first in 2006, the process-oriented ISO 15378 standard picks up this idea. Based on the internationally accepted ISO 9001 Quality Standard, it contains all the GMP requirements relevant to primary packaging material, such as batch tracing, risk management, validation, and controlled environment. ISO 15378:2017 applies to all manufacturers of packaging materials that come into direct contact with the medicinal products. The standard covers all the usual materials, such as glass, rubber, aluminum, and plastics. This standard is now aligned with ISO 9001:2015 and has same 10 element high level structure. ISO 15378:2017 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials. With a thorough understanding of ISO 13485:2016 Standard and its application in a wide variety of industries, countries and businesses of different sizes, Quantum Systems can assist you to develop and implement an ISO 15378:2017 based Quality Management System specific to the needs of your organization. Quantum Systems provides Consulting, Training, Internal Audit, Pre-Assessment Audit and Facilitation during ISO 15378:2017 Certification Audit.
Principles
Principles of ISO 15378:2017 Certification
Customer Focus
Leadership
Engagement of People
Process Approach
Evidenced Based
Decision Making
Strategic Relationship Management
Continual Improvement
benefits
Benefits of ISO 15378:2017 Certification
Ensures that the Organization conforms to all applicable Statutory and Regulatory Requirements.
Improves Customer Satisfaction through a PDCA Processes of Continual Improvement.
Provides International Recognition, Branding, Credibility & Competitive Advantage.
High Level Structure (HLS) makes the Standard Compatible with other ISO Standards for Integration.
Streamlines Business Performance and Operational Controls thereby reducing Rejections and Overheads.
Increases the Organization’s Business Revenue, Profitability and Return on Investment.
Improves Operational Efficiency through Reliable Production Scheduling and Delivery.
Improves Consistency in terms of Products & Service Quality by meeting Customers’ Needs.
Provides Suppliers with greater confidence thereby building Mutually Beneficial Relationship.
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