ISO 15378:2011

ISO 15378:2011 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.

ISO 15378:2011 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

ISO 15378:2006

Certification of your operation against the ISO 15378 standard, you mitigate your risks especially related to contamination, mix-ups and errors. Further, you ensure your customers of the compliance of your QMS.

QAB-CAB provides reliable, independent ISO 15378 certification for your pharmaceutical packaging materials manufacturing operation. During your audit prior to certification we analyze your operation, identifying strengths and outlining the areas where improvement is necessary.  QAB-CAB is a globally recognized leader in certification for the pharmaceutical sector. The QAB-CAB global network of auditors understand your manufacturing processes and the precise meaning of all aspects of the standard. The ISO 15378:2006 standard includes a number of important QMS guidelines  for primary manufacturers of glass, plastic, rubber, aluminum and other materials used for medicinal packaging, including:

  1. Compliance to legal requirements
  2. Identification, reduction and control of risks including contamination and manufacturing errors
  3. Improved efficiency and cost-effectiveness in your operation
  4. Partner with QAB-CAB when you need to demonstrate your ability to quality provide packaging materials for the pharmaceutical industry and help improve patient safety. Contact us today to learn more about ISO 15378 – Primary Packaging for Medicinal Products certification.

ISO 15378:2006 BENEFITS

Obtaining certification to this standard represents an enhancement that brings benefits manyfold:

Improvement in processes

  1. cost minimization for certified organization
  2. additional assurance of quality products to your customers
  3. minimization or elimination instances of contamination
  4. reduction in mistaken mix-ups
  5. reduction of manufacturing errors
  6. Evidence of adherence to legal requirements and contractual obligations
  7. Reduction and control of risks
  8. Clear statement of the organization’s competence
  9. Creates competitive advantages
  10. Improves quality capability
  11. Saves time and costs

The ISO 15378:2006 includes important QMs guideline for primary manufacture of glass, plastic, rubber, aluminum and other medical packaging materials.

The standard also provide framework for legal compliance, identification, traceability, validation, reduction and control of risks (like contamination and our production defects).

Published first in 2006, the process-oriented ISO 15378 standard picks up this idea. Based on the internationally accepted ISO 9001 quality standard, it contains all of the GMP requirements relevant to primary packaging material, such as batch tracing, risk management, validation, and controlled environment. A certificate to ISO 15378, with its holistic approach to GMP and quality requirements, is recognized throughout the world. It provides manufacturers of primary packaging materials with a suitable qualification for customer approval – as well as improving the organization’s image in the eyes of the authorities. ISO 15378 applies to all manufacturers of packaging materials that come into direct contact with the medicinal product. The standard covers all of the usual materials, such as glass, rubber, aluminum, and plastics.