ISO 15378:2006

Primary Packaging Materials for Medicinal Products, Particular Requirements for the Application of ISO 9001:2000 with Reference to Good Manufacturing Practice (GMP)

Combining ISO 9001 and Good Manufacturing Practice (GMP), ISO 15378 specifies the requirements for quality system management and the application for the design, manufacture and supply of primary packaging materials for medicinal products.

Pharmaceutical companies and their packaging suppliers can rely on this standard to help:

• Minimize or eliminate instances of contamination, mix-ups, and errors.
• Reassure business partners and customers of commitment to quality
• Protect customers from purchasing potentially ineffective or dangerous products

The introduction of ISO 15378 gives companies in the pharmaceutical sector a more direct path to implement Good Manufacturing Practices and quality management.

Advantages

LNE/G-MED America has the necessary expertise to certify organizations under ISO 15378 in conjunction with other standards to provide fair, thorough assessment, which stands up to regulatory scrutiny. In addition, you benefit from:

• Local Washington, DC based office with qualified auditors throughout North America to increase convenience and minimize travel costs
• Simultaneous certification for CE Marking, Quality Management Systems (ISO 9001, ISO 13485, ISO 14001) and other standards often performed by a single, highly-qualified auditor, to save you time and expense
• Widely recognized LNE/G-MED expertise as a European Notified Body (CE 0459), as an Accredited Certification Organization by France's accreditation body COFRAC, as a Registrar accredited by the Standards Council of Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS) and recognized by Health Canada and as a Third Party Accredited Person by the U.S. FDA
• Added services, such as product testing (EMC, electrical, mechanical, CB Scheme), product certification, pre-assessment audits and fast-track or onsite review for CE Marking

Find Out More

LNE/G-MED America offers in-person, online and other customized training on a wide range of certification and quality topics. For details, check out our training schedule or request a customized program.

Contact LNE/G-MED America

• For proposals or other service questions: contact customer service
• Ask our experts to submit specific questions to our technical team