ISO 15378 – Primary Packaging Materials for Medicinal Products

ISO 15378 standard 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. This process oriented ISO 15378 Standard, first published in 2006 incorporates in a single document based on the quality management system requirements of ISO 9001 together with the Principles of Good Manufacturing Practice (GMP) relevant to the design, manufacturing and supply of primary packaging materials for medicinal products.  The application of GMP principles provides assurance that the pharmaceutical packaging materials meet the regulatory and pharmaceutical industry requirements.


ISO 15378 specifies requirements for a QMS where an organization needs to demonstrate its ability to consistently provide primary packaging materials for medicinal products.. In addition to the requirements contained in ISO 9001:2000/2008, ISO 15378 contains a list of additional specific requirements unique to the primary packaging sector, such as: Risk management, Batch/ Lot traceability, Validation of critical processes, and Environmental control.


Obtaining certification to this standard represents an additional assurance of quality products to your customers. In addition, being certified to this standard allows organizations to achieve their quality goals and objectives and ensures continual improvement of their manufacturing processes.


The benefits of certification:

  • Helps organizations in the pharmaceutical sector to minimize or eliminate instances of contamination, mix-ups, and manufacturing errors
  • Provides guidance on risk management and validation
  • Improves efficiency and cost effectiveness of your business operations
  • Ensures consistently meet customer requirements, including regulatory requirements
  • A competitive advantage


Our approach

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. 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 600 companies obtain certification, of which, majority have obtained certification with zero deficiencies. Please contact us for details…….