WHAT IS ISO 15378?
ISO 15378 is the international standard for quality management in the production of primary packaging materials for the pharmaceutical industry.
ISO 15378 goes beyond the requirements of ISO 9001 by combining these with specific requirements for Good Manufacturing Practice (GMP). The standard covers, among other things:- Traceability at batch level
- Risk management and validation
- Controlled production environments
- Compliance with applicable authority requirements and regulatory standards
Our certification confirms that we systematically and can document compliance with these requirements, and that we work consistently with quality throughout the entire value chain.
COMPLIANCE IN PACKAGING
We go beyond the standard!
At ApodanNordic PharmaPackaging, we have developed our own internal quality standards – compliance in packaging – ensuring that we do not just meet the minimum requirements but actively raise the bar for quality and documentation.
WHAT ARE THE BENEFITS FOR YOU AS A CUSTOMER?
- Meets the needs and requirements of the pharmaceutical industry
- Complies with GMP principles in production and control
- Understands the importance of direct contact with medical products
- Has quality systems that support documentation
- Ensures traceability, cleaning and possible sterilization of packaging
If you are interested in learning more about the certification, read more here.
At ApodanNordic PharmaPackaging, we are committed to being your preferred supplier of pharmaceutical packaging. Our ISO 15378 certification is your guarantee that our products meet the highest quality standards set by both industry and regulatory authorities.