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.
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:
ISO 15378:2006 BENEFITS
Obtaining certification to this standard represents an enhancement that brings benefits manyfold:
Improvement in processes
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.