What is ISO 15378?

What is ISO 15378


Another one that belongs to the family of ISO standards is ISO 15378, which is also known to be the primary packaging for medicinal products. Any pharmaceutical and medical device includes primary packaging materials like glass, plastics, rubber, films, laminate containers, foils, and aluminum containers or components.

These packaging materials delegate direct contact with medicinal and pharmaceutical products. With this, the materials must have been guaranteed to be safe, efficient, and reliable as required. Suppliers of these packaging materials must attain and adhere to the expectations of medicinal product manufacturers and follow strict compliance in accordance with the expected quality levels.

The expected quality levels must have the integrity of quality management systems (QMS) as well as good manufacturing practice (GMP) upon the process of the products. ISO 15378 is the standard, which demonstrates the demand for a quality management system for the manufacturers of the primary packaging materials for medicinal and pharmaceutical products or devices.

Requirements of ISO 15378

This ISO standard specifies requirements upon which an organization must follow to ensure a quality management system:

  • The capacity to demonstrate a consistent pattern upon the provision of products and services that adhere to customer expectations and applicable statutory and regulatory requirements
  • The demand to improve the satisfaction of customers upon the efficient application of the system, which includes the processes upon enhancing the system as well as the commitment to conform and adhere to the customer and applicable statutory and regulatory requirements.

Why is ISO 15378 Important?

ISO 15378 is important for manufacturers of medicinal and pharmaceutical products, its suppliers, and the producer of primary packaging materials for like products. The requirements of ISO 15378 apply to the medicinal and pharmaceutical sector as a whole – whether it is a small or medium enterprise or too large corporations.

So what makes it important? As manufacturers of pharmaceuticals and medicinal products, it is highly expected that the production and work environment remain sanitary and safe from hazardous elements.

Due to the sensitivity of this industry, there is strict adherence to different kinds of statutory, rules, and regulations coming from several national and international agencies. Thus, the issuance of an ISO 15378 ensures that the organization complies with all the requirements as stated above in this article. It also takes into account the quality management system as stated in ISO 9001 and environmental standards to ensure that the workplace reduces its environmental footprint as well as its contamination and safety hazards.

ISO 15378 also provide benefits such as:

  • Reduction of errors in the manufacturing of medicinal and pharmaceutical products through the application of risk management techniques
  • Improves the products efficacy and shelf life
  • Highly competitive advantage over non-conforming organizations
  • Quality assurance of products to the organization’s consumers
  • Prevents the organization from product contamination, errors, and hazardous elements
  • Optimizing business operations by reducing costs and wastes and improving the overall business processes

Congratulations! You have just reached the end of this article and now learned the importance of ISO 15378 to pharmaceutical and medicinal manufacturers and their suppliers!