ISO 15378 CERTIFICATION

Primary packaging materials for pharmaceutical products require a high level of care during manufacturing, with strictly controlled production processes, due to the presence of multiple contamination risks.

In addition, compliance with product and process - related regulations and legislation is a critical factor.

For manufacturers and companies in the pharmaceutical sector involved in primary packaging materials, operating in accordance with Good Manufacturing Practices (GMP) certification is mandatory. To minimize divergent interpretations, ISO 15378 standardizes the requirements related to the Quality Management System (ISO 9001) and establishes rules governing the design, manufacture, and supply of primary packaging materials for medicinal products.  

WHAT IS ISO 15378?

Good Manufacturing Practices (GMP) certification is a set of practical guidelines, operational rules, and organizational instructions designed to control human, technical, and administrative factors that may affect product quality. The objective of GMP is to define practices that ensure the final product fully meets consumer safety requirements.

ISO 15378 - Primary packaging materials for medicinal products: Particular requirements for the application of ISO 9001, with reference to GMP - ensures product safety and quality, regulatory compliance, process optimization, and risk reduction. These GMP requirements are developed based on a balance between scientific foundations, practical feasibility, and economic considerations, and are agreed upon following extensive consultation and contributions from key stakeholders. The standard is specifically intended for organizations of all sizes involved in the manufacture of packaging or packaging materials for the pharmaceutical industry. 

BENEFITS OF ISO 15378 CERTIFICATION

• Verification of the conformity of the Quality Management System with updated requirements
• Demonstration that the organization and manufacturing activities comply with GMP, with compliance periodically assessed by an independent third - party body
• Enhanced customer trust through assurance of compliance with requirements for primary pharmaceutical packaging materials
• Guaranteed access to European and global markets with a competitive product in a complex and highly competitive environment
• Improved operational efficiency and corporate image
• ISO 15378 certification is internationally recognized

HOW TO OBTAIN ISO 15378 CERTIFICATION

Bureau Veritas, with its expertise in the Healthcare sector, provides ISO 15378 certification services. The main stages of the certification process include:

• Definition of the certification scope
• Preliminary assessment (upon request)
• Certification audit
• Issuance of the certificate of conformity (valid for three years)
• Surveillance audits (typically conducted annually) to monitor and promote continuous improvement

After each audit, the organization receives a clear and comprehensive report to support continuous improvement in product safety management performance.

FAQ – FREQUENTLY ASKED QUESTIONS ABOUT ISO 15378 CERTIFICATION

BUREAU VERITAS: A TRUSTED PARTNER  

Bureau Veritas is a trusted partner, recognized as an ISO 9001 Certification Body by more than 35 national and international accreditation bodies worldwide. As a global market leader, Bureau Veritas Certification has certified over 300,000 organizations in 100 countries and employs a highly trained and experienced team of auditors in the healthcare sector.