AFAQ ISO 15378 certification, quality assurance of pharmaceutical packaging
AFAQ ISO 15378 certification, quality assurance of pharmaceutical packaging
Pharma industry

AFAQ ISO 15378 certification, quality assurance of pharmaceutical packaging

Laboratories or manufacturers of primary pharmaceutical packaging may find it worthwhile to certify the safety of the products or the quality of the manufacturing processes. ISO 15378 certification provides worldwide recognition as well as improved productivity and customer satisfaction.
In this article, we explain, in detail, the main advantages of ISO 15378.

ISO 15378 certification: what is it?

ISO 15378 is an international voluntary standard published in 2006. It is available to companies and organizations that design, manufacture, package, supply or control the materials (glass, plastic, aluminium, etc.) used in pharmaceutical packaging. It represents a standard and a guarantee of safety and quality for primary pharmaceutical packaging. This standard meets the requirements of the ISO 9001 standard (for quality management) and GMP (good manufacturing practices). ISO 15378 certification is issued for three years and a surveillance audit is performed each year.

ISO 15378: what are its advantages?

ISO 15378 certification offers several advantages.

Worldwide recognition

This globally recognized standard enables businesses to stand out in the national and international markets. It also helps to promote the safety and quality of pharmaceutical packaging products worldwide.

Reducing risk and improving customer satisfaction

ISO 15378 makes it possible to identify, control and thus reduce the risks of contamination, manufacturing errors, etc. This increases consumer safety and therefore their level of confidence and satisfaction.

Compliance with legal requirements

It proves the compliance of pharmaceutical packaging materials with national or international standards and regulations in force in the pharmaceutical industry.

A powerful management tool that will improve your results

This certification provides access to an effective management tool that enables the implementation of a more efficient management system. In this way, it improves practices and performance in terms of safety and quality.

AFAQ ISO 15378 certification: Afnor Certification and some figures

It is important to note that the ISO 15378 certification is developed by AFNOR Certification.

AFNOR Certification:

  • is the first French certifying body to be accredited by a recognized body, COFRAC (French Accreditation Committee);
  • has over 20 years’ experience, with more than 70,000 certified customers;
  • has a presence throughout France and in more than 100 countries;
  • offers extensive training to help you better understand and apply the standards.