ISO 15378
Certification of primary packaging for medical products with reference to GMP rules
 

• The standard specifies the requirements for a quality management system as well as the applications for design, manufacture and supply of primary packaging materials for medicinal products.
• As a consequence of the direct contact of the product with the packaging (contamination risk), the implementation of GMP in production and the control of primary packaging materials are of high importance for the security of the patients.
• The application of GMP for pharmaceutical packaging materials guarantees that the legal requirements and the standards of the pharmaceutical industry for medical devices are met.
• The certification of a company according to ISO 15378 confirms that the GMP rules are applied and that the company operates based on an effective and efficient management system.

Target groups

 Companies and organisations which manufacture, pack and control primary packaging materials for medicinal products (medical devices). Medicinal products are defined as substances or preparations developed to help cure or prevent diseases in humans or animals.

• Implementation of and compliance with the generally applicable GMP principles of the pharmaceutical industry
• Reduction of client audits through certified system
• Certificate issued by an accredited certification body

• 3 years
• International

• With all other ISO standards (9001, 14001, 18001, all in one)
• Suitable for manufacturers (not traders) of medical devices (alternative to ISO 13485)

Information
Ulrich Röhr