Enhance your pharmaceutical packaging quality management system with ISO 15378-2017 certification.
Our experts will guide you through the certification process to ensure your packaging meets global standards for safety and quality.
ISO 15378:2017 is an international standard that specifies requirements for a quality management system in the production of primary packaging materials for medicines. It is designed to ensure the safety, quality, and integrity of packaging used in the pharmaceutical industry. The standard incorporates Good Manufacturing Practice (GMP) principles, focusing on risk management, process control, and continuous improvement. ISO 15378:2017 helps manufacturers meet regulatory requirements, enhance product protection, and ensure compliance with both industry standards and customer expectations.
We begin by understanding your organization's needs and requirements. This helps us recommend the right certification process for you.
We review your existing processes, policies, and documents to ensure they meet the standards for ISO certification.
We provide guidance and support to implement the necessary changes and improvements to meet the ISO standards.
We perform an internal audit to assess your organization's compliance with the ISO standard and ensure everything is in place.
A third-party certification body conducts the final audit to ensure your organization meets all the requirements for ISO certification.
Once you pass the audit, the certification body issues the ISO certificate, confirming your organization’s compliance with the ISO standards.
Essential documents for ISO Certification
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