ISO 15378:2017 Primary Packaging Materials for Medicinal Products (GMP)


ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.

ISO 15378 requirements include compliance to ISO 9001 and Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials 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.

Good Manufacturing Practice (GMP) is a term that is renowned worldwide for the control and management of manufacturing, testing and final quality control of food / beverage and pharmaceutical goods and their primary packaging. GMP is a set of rules that gives you the affirmation that your item is safe. GMP is responsible for the safety, efficiency, and quality of pharmaceutical products, cosmetic products and edible products and their primary packaging.

The quality approach of GMP guarantees to enable organizations to limit or eliminate instances of contamination, mistakes and errors. This thus shields the customer from purchasing an item, which isn’t effective or even dangerous. It is accepted that GMP is one of the best business tools, which will refine both the compliance and performance of the organization.

Evolution of ISO 15378 and Revision History

  • Year 2006 – ISO 15378 standard was published
  • Year 2011 – 1st Revision of the standard
  • Year 2015 – 2nd Revision of the standard
  • Year 2017 – 3rd Revision of the standard

Eligibility / Applicability (Which organizations can avail ISO 15378 certification??)

The certification is availed primarily by the companies which are into design, manufacture and supply of primary packaging materials for medicinal products. This standard can also be used in other industry sectors when a quality management system with additional requirements over an ISO 9001:2015 system is needed.

NOTE : The eligible organizations shall be able to furnish data related to primary packaging materials for medicinal products while certification audit.

Focus Points – ISO 15378:2017 Implementation

  • Integration of customer requirements specific to primary packaging materials for medicinal products
  • Streamlining and Standardizing the manufacturing processes and other business processes
  • Manufacturing Process Control and Monitoring
  • Risk management and Contingency planning
  • Formulating Quality Policy and Objectives
  • Setting up system for documentation and records.
  • Management information system
  • Business performance and sustainability

Benefits of ISO 15378:2017 Implementation

  • Entry passport for supply to the customers from pharmaceutical field.
  • Recognition of the certificate and the system by other industry sectors
  • Cost effectiveness at various stages of the operations of the organizations
  • Improved product safety and warranty management
  • Manufacturing process controls enhancing Quality and Productivity
  • Business process streamlining and efficiency improvement
  • Responsibility and Accountability across the organization
  • Better business performance and Enhanced sustainability

ISO 15378:2017 Implementation Process by PQSmitra

ISO 15378 being a specific standard for primary packaging materials for medicinal products, the required controls and monitoring of the quality management system and actual on floor practices are very specific and stringent. In such scenario, the practical, easy and effective implementation of the system is very essential. PQSmitra team with an expertise more than 20 years has supported many clients implement GMP and get ISO 15378 certification.

The ISO 15378:2017 implementation process is described below:

  • Review of the existing Quality Management System. This review is carried out through discussions and verifications of records during visits to the client organization. The pharma customer specific requirements are taken into consideration to make this activity effective.
  • GMP based system designing and documentation (Records and Procedures). 100% documentation support is offered by PQSmitra. This includes shop floor controls as well as control on documentation and records.
  • Training on GMP and QMS related requirements
  • Routine assistance and system verification to ensure compliance to the requirements.
  • Internal audit and Management review
  • Certification audit – Stage 1 and Stage 2
  • Submission of action plan on audit observations
  • Review of report by the certification authority and awarding the certificate to the organization

ISO 15378:2017 Reference Standards

  • ISO 9000:2015 – Quality management – customer satisfaction – Guidelines for complaint handling in organizations
  • ISO 10012, Measurement management systems – Requirements for measurement processes and measuring equipment