The certification for primary packaging manufacturers for medicinal products

ISO 15378 is an internationally valid standard for manufacturers of pharmaceutical packaging that comes into direct contact with medicinal products. With ISO 15378 certification, your company can demonstrate that its products meet high international standards for pharmaceutical packaging.

Compliance with regulatory and contractual requirements

Sustained time and cost savings

Reduced risks

Increased process control

Assurance of high-quality standards

Beschreibung Standard/Regelwerk

Demonstrate strong safety and quality standards for pharmaceutical packaging

The ISO 15378 standard is aimed at companies that manufacture primary packaging for medicines. It was first published in 2006 and aims to improve the quality and safety of medicinal products.

With an ISO 15378 certification, manufacturers of pharmaceutical packaging fulfill central compliance requirements and ensure compliance with national, European, and international legal requirements. Among other things, the standard considers legal requirements from the German Medicines Act, the Pharmaceuticals and Active Ingredients Manufacturing Ordinance, and the Food and Drug Administration (FDA).

The ISO 15378 standard also fulfills all important requirements for Good Manufacturing Practice (GMP) and the requirements of ISO 9001 for a quality management system.

Primary packaging materials such as glass, rubber, aluminum, or plastic that come into direct contact with the drug product are covered.

Show more
Show less

What are the requirements for my company to obtain an ISO 15378 certification?

ISO 15378 goes beyond the requirements of ISO 9001 and it must be possible to trace batches. There must also be risk management, validations, and controlled environmental conditions.

All GMP requirements related to packaging quality must be met to have a successful audit.

Show more
Show less

How ISO 9001 creates a GMP basis for ISO 15378

The ISO 15378 standard enables you to meet the legal requirements for primary packaging materials for medicinal products and medical devices. It contains the requirements of ISO 9001 as well as the principles of Good Manufacturing Practice (GMP).

GMP is required by all regulatory requirements for the pharmaceutical and medical device industries internationally. These include the Code of Federal Regulations (USA), European guidelines, and Indian regulations.
Adherence to GMP not only fulfills compliance but also ensures more efficient production processes.

Show more
Show less
Chancen und Risiken

How can a GAP analysis be useful before the ISO 15378 audit?

A GAP analysis helps you to understand the requirements of ISO 15378 and to implement the requirements for your quality management system as well as the principles of good manufacturing practice according to the ISO 15378 standard.


What are the steps to achieve of an ISO 15378 certification?

In the first step, you discuss your company and the goals of ISO 15378 certification with us. Based on these discussions, you will receive an individual quote customized to the needs of your company or organization.

These steps prepare for the actual audit. A project planning meeting can be useful for larger projects to plan schedules and conduct audits for individual sites or departments. A pre-audit provides an opportunity to identify system strengths and areas for improvement in advance.

The certification audit starts with an analysis and evaluation to determine whether your management system is ready for certification. In the next step, your on-site DQS Inc. auditor evaluates the effectiveness of the management processes using the standards. The results are presented at a final meeting and, if necessary, action plans are agreed upon.

After the audit, the results are evaluated by the independent certification board of DQS Inc. If all requirements are met, you will receive the ISO 15378 certificate.

Either semi-annually or annually, key components of the system are re-audited on-site for further improvements. The certificate expires after a maximum of three years, but recertification is performed by DQS Inc. before expiration to ensure continued compliance.


How much does ISO 15378 certification cost?

The cost of ISO 15378 certification depends on several factors. Whether a certified management system has already been implemented plays an important role.

The size of your company and the complexity of your quality management system influence the duration of the audits and their costs. The cost of certification will vary depending on the needs of each organization. We are happy to make you an individual quote for your company, organization, or authority.

Show more
Show less

Why should companies get certified with DQS Inc. according to ISO 15378?

  • Extensive expertise and industry knowledge in the healthcare sector
  • Personal contacts at many locations worldwide
  • High level of customer orientation and service quality
  • Required audits in the medical sector from one source
  • Support in the US and internationally

Basic data for ISO 15378 (primary packaging materials)

If your company is interested in certification based on ISO 9001 and / or ISO 15378 standards, you have come to the right place.

We are happy to provide you with a  cost estimate free of charge and with no obligations. For this we need some information about your organization. Please fill in the basic data for ISO 9001/ ISO 15378 completely and send it to us.

Download now

Request a quote

Your local contact

We will be glad to provide you with a customized quote for ISO 15378 certification.