ISO 15378 standard for primary pharmaceutical packaging: complete guide

2. Why is ISO 15378 essential for primary pharmaceutical packaging?

Pharmaceutical products and dietary supplements are sensitive to external factors, such as chemical, biological, or physical contaminants. Therefore, choosing primary packaging that meets strict quality standards is essential.

The ISO 15378 standard ensures that materials used for packaging meet safety and regulatory compliance requirements.

ISO 15378 requirements address the needs for quality, traceability, and safety in manufacturing processes. By integrating GMP specific to the sector, the standard reduces non-compliance issues and potential contamination risks.

Pharmaceutical GMPs are an essential benchmark in the pharmaceutical industry. Check out our complete guide to pharmaceutical GMPs.

3. Requirements covered by the ISO 15378 standard

The requirements of ISO 15378 are based on three main areas:

• Quality and security: The standard requires rigorous risk management, process validation, and the implementation of appropriate quality controls to meet regulatory and safety requirements.
• Traceability: Traceability is essential in the pharmaceutical industry. ISO 15378 mandates batch tracking systems and rigorous document control, ensuring the recording and verification of each production step.
• Training: For proper application of the ISO 15378 standard, personnel must be trained. The standard emphasizes continuous training to ensure compliance and prevent human errors.

These requirements ensure pharmaceutical products meet international safety and quality standards, strengthening companies’ credibility with health authorities and consumers.

To learn more about the different ISO standards in pharmaceuticals, check out our complete article.