ISO 15378 certification: Certification of primary packaging materials


ISO 15378 certification: Certification of primary packaging materials for medicinal products is essential to ensure the protection of patients and users.
Primary packaging refers to the container with which the medicinal product is in direct contact. It is therefore only natural to pay particular attention to it. Medicinal products are very fragile and sometimes dangerous which require special attention during handling. Meeting packaging quality and safety requirements in the pharmaceutical industry is a key issue for all companies in this sector

What is ISO 15378 : Primary packaging materials for medicinal products ?

Qu'est-ce que

ISO 15378 certification governs the manufacture of primary packaging materials for medicinal products. This international standard establishes the conditions and best practices for manufacturing medicinal product packaging in order to guarantee the safety of users. 

Its main objectives are: 

  • Ensuring the safety of patients and users of packaging materials
  • Guaranteeing compliance with the good manufacturing practices for packaging materials

Who should attend ISO 15378 : Primary packaging materials for medicinal products

A qui s'adresse

The ISO 15378 standard is for medical product laboratories and packaging manufacturers.

This certification is a management tool for harmonising the practices of the upstream sector of the pharmaceutical industry. 

The characteristics

Les caractéristiques

The ISO 15378 standard is an internationally recognised common management tool for companies. This certification allows a company to demonstrate its commitment to the safety of packaging of pharmaceutical products.

It meets the requirements of ISO 9001 while taking into account Good Manufacturing Practices (GMP)



ISO 15378 certification is a voluntary approach that reflects the social commitment of organisations. The valid period of the ISO 15378 certificate is 3 years. Renewing the certification requires a renewal audit. 

Procedures for obtaining certification: 

However, in order to submit your certification application under the best conditions, to facilitate its acquisition, and to better meet the requirements of the ISO 9001 standard, it is recommended:

  • That your quality management system has been running for 6 months,
  • That it has been audited internally at least once,
  • That a management review has been carried out.

The benefits of ISO 15378 : Primary packaging materials for medicinal products

Bénéfices de cette certification

ISO 15378 certification offers many advantages for your organisation and allows you to: 

  • Guarantee patient safety by limiting the risk of contamination of products in direct contact with packaging
  • Ensure pharmaceutical packaging materials meet pharmaceutical industry medicinal product requirements.
  • Certify that the recognised GMP rules are respected and that your company has an effective and efficient management system
  • Optimise your organisation’s profitability thanks to efficient organisation
  • Identify and reduce risks and manufacturing errors to keep your staff, your company and users safe
  • Promote the quality of your production to your partners and customers

Why choose Apave

Pourquoi choisir Apave

Apave Certification, a subsidiary of the Apave group, has solid expertise based on the large amount of customer feedback it has had for over 150 years.

Apave Certification, an independent third party, supports you in your certification procedures, whether voluntary or regulatory. We operate throughout France and internationally with our network of qualified auditors and laboratories.

The key features of Apave Certification

  • A structure on a human scale with an approach focused on the needs of our customers.
  • A network of qualified auditors and assessors, selected with care to provide the best quality service.
  • Wide geographical coverage enabling great responsiveness and control of deadlines
  • Personalised support with the possibility of creating a customised certification or reference framework.
  • Obtaining a known and recognised certificate at national and international level thanks to our numerous accreditations

Steps and processes

Etapes et processus

To obtain certification, Apave Certification supports you during the 6 stages leading to the issue of the ISO 15378 certificate:

  1. Initial certification request
  2. Scheduling the audit between the audited organisation and Apave Certification:   
  3. Initial certification audit
  4. Certification decision
  5. Issuing the certificate
  6. Annual follow-up audit


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Apave Certification's services are based on 5 major areas: Management systems Skills certification (DPO...) Product certification (CB Scheme...) Services (Qualiopi) Labels / Evaluations (HS2...)

Independent third party
Apave Certification is a recognized and independent certification body specialized in certification engineering.

Apave Certification works quickly, throughout France and internationally, and keeps deadlines under control.

Apave Certification relies on a large geographical network of qualified internal and external auditors, both nationally and internationally.

Apave Certification is a flexible structure with a customer-oriented approach, which is involved in both voluntary professional certifications and regulatory and mandatory certifications.

Apave Certification, a subsidiary of the Apave group, benefits from solid expertise based on extensive customer feedback over more than 150 years.

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Apave Certification holds numerous accreditations and recognitions, guaranteeing our quality and technical systems and proving our competence, know-how and independence.




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