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DIN EN ISO 15378

Standard for Primary packaging materials for medicinal products

The ISO 15378 applies to manufacturers of primary packaging materials which are in direct contact with the drug. The standard covers all common materials used for primary packaging such as glass, rubber, aluminium and plastic. With the ISO 15378, all contract manufacturer of these materials or rather manufacturers, who pack such materials themselves, can secure early a high GMP standard and international acceptance. For suppliers of primary packaging materials of pharmaceutical products, the standard contains all relevant GMP requirements and enables compliance with international, European and national legal regulations.

Since its publication in 2006, the ISO 15378 is gaining increasingly importance. It includes many statutory requirements from the Medicines Act, Pharmaceuticals and Active Agent Manufacturing Ordinance and the Food and Drug Administration (FDA) to manufacturers of medicinal products. Through this set of rules and regulations specific requests to a supplier of primary packaging materials are available, as all relevant requirements to Good Manufacturing Practice (GMP) are included. The ISO 15378 is process-oriented and in addition to industry-specific includes all requirements of ISO 9001 for a quality management system. With its holistic approach of GMP and quality requirements ISO 15378 corresponds to the state of the technology.

Primary packaging manufacturers must also meet in addition to the ISO 9001 requirements, a number of other criteria, such as inter alia batch traceability, risk management, validation and controlled environmental conditions. The unique questionnaire on the quality relevant GMP requirements is the basis for the qualification and approval of suppliers. An ISO 15378 certificate enhances the reputation of companies with their customers and towards authorities and provides the following benefits:

  • Proof of compliance with statutory regulations and contractual agreements
  • Reduction and control of risks
  • Presentation of the company's expertise
  • Creation of competitive advantages
  • Improvement of the quality capability
  • Time and cost savings