ISO 15378: QMS Certification, Advantages, Applications, and it’s RequirementsPosted by certification consultancy on October 31st, 2023 ISO 15378:2017 is a standard that specifies the standards for the manufacture, packing, and storage of principal packaging materials for pharmaceutical products. The standard is intended to ensure that primary packaging materials are created and handled in a manner that fulfils the pharmaceutical industry's exacting requirements. It is also meant to ensure that these materials are of the highest quality and satisfy the unique needs of the pharmaceutical sector. The standard is intended to assist pharmaceutical businesses in meeting regulatory requirements, such as Good Manufacturing Practice (GMP) for packaging materials, by providing a framework for the construction of a QMS that can be audited and certified. What is ISO 15378:2017 Certification? ISO 15378:2017 is a Quality Management System (QMS) certification standard that outlines the standards for pharmaceutical main packaging materials. The standard focuses on Good Manufacturing Practices (GMP) and guaranteeing the safety, quality, and consistency of drug-making components. The ISO 15378:2017 standard establishes guidelines for the design, development, manufacturing, and distribution of pharmaceutical packaging components such as containers, closures, and labels. The standard also contains risk management, quality control, and documentation requirements. Pharmaceutical packaging manufacturers can demonstrate their dedication to delivering high-quality products that comply with industry laws and meet consumer expectations by acquiring ISO 15378:2017 certification. What are the Advantages of ISO 15378:2017?
Application of ISO 15378:2017
Requirements of ISO 15378:2017 The following sections define ISO 15378 requirements:
How will Certificationconsultancy.com Help to Achieve ISO 15378 Certification? We provide an ISO 15378 certification consulting for primary packaging materials used in the production of medical products. Our ISO 15378 documentation kit can assist users in making the certification process more efficient and successful. This kit includes the ISO 15378 manual, procedures, internal audit checklist, exhibits, sample formats, etc in editable formats. Like it? Share it!More by this author |