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.
A certificate to ISO 15378:2017 with its wholistic approach to GMP and quality requirements, is recognized throughout the world. It provides manufacturers of primary packaging materials with a suitable qualification for customer approval – as well as improving the organization’s image in the eyes of the authorities. 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.
This ISO 15378:2017 standard, developed with the participation of pharmaceutical sector experts, incorporates in a single document the quality management requirements of ISO 9001:2015 together with the Principles of Good Manufacturing Practice (GMP) for the design, manufacturing and supply of primary packaging materials for medicinal products.
The ISO 15378:2017 standard includes several important QMS guidelines for primary manufacturers of glass, plastic, rubber, aluminum and other materials used for medicinal packaging, including:
- Compliance to legal requirements
- Identification, reduction and control of risks including contamination and manufacturing errors
- Improved efficiency and cost-effectiveness in your operation
- Process Approach for monitoring effectiveness of the system
- Provision for Continual Improvement of Processes for overall improvements in products and processes
The benefits of certification:
- Helps organizations in the pharmaceutical sector to minimize or eliminate instances of contamination, mix-ups, and errors
- Provides guidance on risk management and validation
- Good selling tool
Our approach: QSE has expertise to offer consultations in ISO 13485 Quality Management for medical devices, ISO 15189 Standard for Medical Laboratories and associated required coaching for HACCP, HARPC and coaching on Good manufacturing practices.
QSE’s “Ten Step Approach”™ to Registration is designed and perfected to cost- effectively prepare facilities for successfully passing Certification Audits with minimum or no nonconformities. QSE emphasizes on developing Simplified Documented Management Systems to meet or exceeds the requirements of any ISO Standard requirements. ISO 15378:2015 has been withdrawn since September 2017. Validity for this standard is only up to 3 years from the date of publication of new standard that is up to September 2020. Certification to old standard stops a year before this date. Hence no new certifications to ISO 15378:2015 beyond September 2019. This 10 Step Approach has a built-in discipline to involve all employees including top management right from the beginning to achieve long-term desired results. Our approach is so complete that we have helped over 700 companies obtain certification, of which, majority have obtained certification with zero deficiencies.
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