The certification for primary packaging manufacturers for medicinal products
Compliance with regulatory and contractual requirements
Sustained time and cost savings
Increased process control
Assurance of high-quality standards
Demonstrate strong safety and quality standards for pharmaceutical packaging
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.
What are the requirements for my company to obtain an ISO 15378 certification?
All GMP requirements related to packaging quality must be met to have a successful audit.
How ISO 9001 creates a GMP basis for ISO 15378
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.
How can a GAP analysis be useful before the ISO 15378 audit?
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 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.
Why should companies get certified with DQS Inc. according to ISO 15378?
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.