ISO 15378 – Primary Packaging Materials for Medicinal Products
- Industry: Pharmaceuticals & Medical Devices; Packaging Safety, Quality, and Compliance
About ISO 15378
ISO 15378 combines the quality management principles of ISO 9001 with Good Manufacturing Practices (GMP) specific to primary packaging materials used in the pharmaceutical industry. It ensures materials such as vials, bottles, blister packs, and closures meet strict regulatory and quality expectations.
Why ISO 15378 Certification Matters
- Regulatory Compliance: Helps manufacturers meet FDA, EMA, and WHO requirements for pharmaceutical packaging.
- Product Integrity: Minimizes contamination risks and ensures packaging materials do not affect the safety or efficacy of the medicinal product.
- Improved Supplier Relations: Demonstrates reliability and transparency to pharmaceutical manufacturers and regulators.
- Risk Reduction: Enhances traceability, documentation, and defect prevention in packaging operations.
- Customer Confidence: Takes a holistic approach to safety and production of packaging materials.
EAGLE’s ISO 15378 Auditing Services
We audit packaging manufacturers on their adherence to ISO 15378 standards. Our audits assess quality systems, GMP practices, traceability protocols, and customer complaint handling to help you achieve certification and improve operational performance.
Benefits of Our Auditing Approach
Expertise:
Our auditors possess deep industry knowledge and understand the nuances of your unique needs.
Tailored Solutions:
We customize our auditing approach to fit your organization's specific needs and operational context.
Partners in Success:
We pride ourselves in becoming your partner in achieving your objectives while taking a consultative approach.
Contact us today to begin the process and take the first step toward achieving certification.