ISO 15378:2017 - PRIMARY PACKAGING MATERIALS FOR MEDICAL DEVICES
What is ISO 15378:2017?
ISO 15378:2018 specifies requirements for a quality management system for manufacturers of pharmaceutical and medical device primary packaging materials. These organizations need to demonstrate their ability to consistently meet customer requirements, including regulatory requirements and international standards applicable to primary packaging materials for such medicinal products.
The standard delineates GMP principles and specifies QMS requirements applicable to primary packaging materials for medicinal products.
The ISO 15378 standard enables you to comply with legal requirements for pharmaceutical and medical device primary packaging materials.
ISO 15378 integrates the requirements of ISO 9001 as well as GMP, a regulatory requirement for the pharmaceutical and medical device industries as per all international regulations such as the Code of Federal Regulations (U.S.), European directives, and Indian regulations. Adhering to GMP principles boosts the efficiency of your production processes.
The standard also helps to reduce the risks of safety hazards and product contamination, and ensure product efficacy and shelf life.
Benefits of ISO 15378:2017 Certification
Customer Satisfaction
Deliver products that consistently meet customer requirements and a service that is dependable and can be relied on.
Save money and time
with a service provider that eliminates the need for multiple assessments and improves productivity through process optimisation.
Improved stakeholder relationships
Improve the perception of your organization with staff, customers, and suppliers.
Legal Compliance
Understand how statutory and regulatory requirements impact your organization and its customers.
Minimise risk
by achieving documented compliance with safety standards, thereby avoiding costly liability.
Gain a competitive edg
by demonstrating the ISO 15378 compliance of your organisation to all stakeholders with a trusted third-party certification partner.
Who can be certified ISO 15378?
All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
The primary packaging material is identified as the material that is in direct contact with the measurement structure. With the involvement in Primary packaging standard which may require any single part of a container closure system which includes containers, container liners, closures, closure liners, stopper oversells, etc.
Ampoules Package
Strip Package
Blister Packaging
Sachet Packaging
Dosing Doppler
Syringe Package
Document required for ISO 15378:2017
- System Manual
- System Procedure
- Policy
- Objectives
- Mission & Vision
- Standard Operating Procedure (SOP)
- Checklist
- Forms
- Formats
- Records
The extent of Documented Information differs as per:
- Organization’s size
- Activities performed by the organization
- Processes undertaken by the Organization
- Products and services offered by the organization
- The complexity of processes undertaken
- Competence of persons involved
Role of Shamkris and Process of ISO 15378:2017 - Certification
Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain a certificate of success in addition to enhanced performance.
The implementation process is described below:
Time Frame
Task
Process
Day 1
GAP Analysis
Certification Body
Selection
Cost Estimates
- Finding the GAP between existing system related to ISO requirements
- Selecting the appropriate certification body
- Based on the scope of your business & certification body you choose
Week 1
Developing Documents
- Management System Manual, Management System Procedures, Policy, Objectives, Forms etc.
- Review of Standard Operating Procedures (SOP)
Week 4
Implementing Management System
- ISO Awareness training for the top management and staff
- Implementing a well-documented management system throughout the organization
Week 8
Internal Audit
MRM
CAPA
- Internal audits identifying nonconformities related to ISO requirements
- Management Review Meetings
- Corrective and Preventive Action plan for nonconformities
Week 10
Certification Body
Audit
N-C Closing
- Shamkris acts on your behalf and assists you in the third-party audit
- Closing of any nonconformities identified by the certification body
Week 12
Certificate Issued
- ISO certificates issued for 3 years
- Surveillance Audits yearly
Year on Year
Yearly Compliance
- Support of Yearly documentation for audit
FAQ
The implementation of an ISO 15378 quality management system improves efficiencies across process control, workflows, costs, wastage reduction, meeting customer expectations, and raising workforce morale. In addition to certification, ISO 15378 can be used in your quality improvement efforts such as training and auditing activities.
The option to serve large companies in the pharmaceutical and medical device industries with medicinal primary packaging is only available to suppliers holding an accredited ISO 15378 certification.
Finally, a robust ISO 15378 quality management system can easily be adapted to an ISO 9001 quality management system. Securing your ISO 9001 certification enables you to expand your service offering to other specialty manufacturing areas, giving you flexibility and adaptability in changing market environments.
Good manufacturing practices are standards provided by the agencies that control and license the manufacturing and sale of food/beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices.
Good Manufacturing Practice (GMP) for primary packaging materials requires suitable provision of personnel, premises, and equipment, in addition to a quality management system that includes controls for incoming starting materials, manufacturing, corresponding documentation, factory hygiene, final inspection, records of distribution, processing of complaints and self-inspection.
Your ISO 15378 proves your ability to perform and deliver to the specific standards of primary medicinal packaging and is a prerequisite for being recognized as a qualified supplier by pharmaceutical sector brands.