
ISO 15378 standard for primary pharmaceutical packaging: complete guide
In the pharmaceutical field, where safety and quality are essential, ISO 15378 represents a specific quality standard for manufacturers of primary pharmaceutical packaging.
This standard is particularly important for the actors in the pharmaceutical and dietary supplement industries, who must ensure that their products reach consumers in perfect safety and integrity.

In the pharmaceutical field, where safety and quality are essential, ISO 15378 represents a specific quality standard for manufacturers of primary pharmaceutical packaging.
This standard is particularly important for the actors in the pharmaceutical and dietary supplement industries, who must ensure that their products reach consumers in perfect safety and integrity.
This article provides an overview of ISO 15378, its requirements, and its benefits for companies in the sector.
1. What is the ISO 15378 standard?
The ISO 15378 standard is an international standard that defines quality requirements for manufacturers of primary packaging intended for pharmaceutical products.
It applies to materials such as glass ampoules, vials, blisters, and other primary packaging that come into direct contact with medicines or dietary supplements.
ISO 15378 specifically targets Good Manufacturing Practices (GMP) for primary packaging, incorporating critical safety and traceability measures for this industry.
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.
4. The benefits for companies complying with ISO 15378 standards
For packaging manufacturers, implementing the ISO 15378 standard offers significant strategic advantages:
- Enhanced reliability and quality: Compliance with ISO 15378 improves packaging quality and safety, reducing the risk of non-compliance.
- Reducing the risk of contamination: By applying GMP-compliant manufacturing practices, the standard reduces the risk of product contamination or damage.
- Trust from client and partners: Customers in the pharmaceutical and nutraceutical industries place more trust in certified companies because they demonstrate their commitment to safety and quality.
- Accessing international markets: ISO 15378 certification is recognized worldwide and facilitates the export of safe, high-quality pharmaceutical and nutraceutical products.
5. SFAM and ISO 15378: A total quality approach
As a manufacturer of double-tip glass ampoules for the pharmaceutical and dietary supplement industries, SFAM has integrated ISO 15378 requirements into its production system.
Complete automation and strict quality control ensure that its double-tip glass ampoules meet the highest safety standards.
The ISO 15378 standard is a key element for manufacturers of primary packaging for pharmaceuticals and dietary supplements. It ensures that packaging materials are produced according to strict quality and safety standards, reducing the risks of contamination and non-compliance.
Adhering to this standard allows companies to ensure the safety of their products while enhancing their credibility with customers and in the international market.