Skip to content

ISO 15378 Certification

ISO 15378 Zertifizierung - Medikamentenverpackungen ohne Beschriftung als Blisterpackungen und als Kunststoffbehälter

Primary packaging for medicinal products must fulfill special requirements

DIN EN ISO 15378 covers the requirements for the quality management system and contains all the requirements of Good Manufacturing Practice (GMP). In addition to design, production and risk assessment, GMP also includes assembly, so that common materials such as glass, rubber, aluminium and plastic for the manufacture of primary packaging are covered. As a non-food standard, ISO 15378 is not recognised by the Global Food Safety Initiative (GFSI).

Instead, the certification is aimed at pharmaceutical companies in the manufacture of primary packaging. Certification enables you as a manufacturer to secure a high GMP standard and international acceptance at an early stage. The fulfilment of manufacturing guidelines is essential in the pharmaceutical industry. Good manufacturing practice guarantees product quality through quality management.

Your ISO 15378 offer

Target group

Manufacturers of primary packaging for medicinal products and medical devices

ISO 15378: Your advantages through certification

  • Process optimization
  • Cost savings
  • Savings in time and effort for second party audits in your own company
  • Competitive advantage through proof of quality
  • International validity in process optimization
  • Risk minimization
  • Building trust with customers and on the market

Certification process of ISO 15378 Z

1

01

Assessment of requirements and preparation of a quotation

2

02

You commission TÜV NORD

3

03

Document review

4

04

On-site audit

5

05

Report and action plan

6

06

Issue of certificate (valid for 3 years)

7

07

Annual monitoring audits

FAQs on ISO 15378 certification

Primary packaging materials for medicinal products and medical devices include containers made of glass, rubber, plastic, aluminium and composite materials as well as films. All materials come into direct contact with the medical product and must fulfill the corresponding safety and quality requirements. As a manufacturer of primary packaging, you must be able to demonstrate that your production processes are subject to a comprehensive quality management system (QMS) and the rules of good manufacturing practice (GMP).

ISO 15378 contains the requirements of ISO 9001 and the principles of Good Manufacturing Practice (GMP). These are required by all legal regulations for the pharmaceutical and medical device industry, such as the Code of Federal Regulations (USA), the European directives and the Indian regulations at international level. By complying with the GMP principles, you can achieve greater efficiency in your production processes. The standard helps you to avoid safety hazards and the risk of product contamination and ensures the efficacy and shelf life of your product.

The management and hygiene certification offered by TÜV NORD is aimed at manufacturers of primary packaging for pharmaceuticals and pharmaceutical manufacturers. For suppliers of primary packaging for pharmaceutical products, the standard includes all relevant GMP requirements and enables compliance with international, European and national legal guidelines.

A GAP analysis (gap analysis) helps you to understand the requirements of DIN EN ISO 15378 and to implement the requirements for your QMS and the GMP principles in accordance with ISO 15378. You carry out an assessment of your organisation with regard to the requirements stipulated by the standard. The gaps identified between the standard and implementation must be closed on the way to certification. A pre-audit allows you to run through the ISO 15378 assessment as a test and incorporate the results into your action plan in preparation for the actual certification audit.

We are here for you!

Philipp Nahrmann

Philipp Nahrmann

TÜV NORD CERT
Sales Certification Food/ Near-Food
Tel.: +49 (0)521 786-327 / foodcert@tuev-nord.de
Send Email
Christian Kienzle

Christian Kienzle

TÜV NORD CERT
International Sales Manager
Tel.: +49 160 8883919 / foodcert@tuev-nord.de
Send Email

ISO 15378 certification from TÜV NORD CERT: How you benefit from us

We provide you with reliable and independent information: Our team of experts will guide you through your entire certification process. Our many years of experience in conducting certifications and the knowledge of a global network of interdisciplinary experts are at your side throughout the entire audit. In this way, we ensure that your audit process remains efficient and clear.

Combinations with management systems (9001, 14001, 45001), BRCGS Packaging or IFS HPC are also possible.

With TÜV NORD CERT as your certification body, you benefit from the worldwide recognition of the TÜV brand. Our seals stand for objectivity, neutrality and expertise.