GMP for Pharmaceutical Packaging and ISO 15378

ISO 15378 is the global standard for primary packaging materials used in pharmaceuticals. It combines ISO 9001:2015 quality management with Good Manufacturing Practices (GMP) to ensure that packaging components (like glass, rubber, aluminum, and plastic) meet the highest standards for safety and regulatory compliance.

Why is it important? Because these materials directly contact the drug. Any failure in their quality can compromise product integrity, trigger recalls, or lead to regulatory penalties. ISO 15378 is now a core requirement in audits by the FDA, ISO bodies, and global pharmaceutical companies.

This certified course gives you the tools to implement ISO 15378 and GMP effectively. Your organization will reduce risk, pass audits, and protect patient safety.

Who should enroll?

• Packaging and production professionals in the pharmaceutical industries
• Quality Assurance (QA) and Quality Control (QC) experts
• Regulatory Affairs specialists
• Packaging operations managers
• Auditors and compliance officers

What you’ll learn?

• Critical roles of primary packaging components in drug safety and efficacy
• GMP and ISO 15378 requirements across global regulations (FDA, EU, WHO)
• Effective management of packaging design and artwork
• Best practices for packaging operations to ensure traceability and efficiency
• How to assess and qualify packaging materials and suppliers

Each module includes real-world case studies, interactive assessments, and tools to apply knowledge in your day-to-day role. Upon successful completion, you’ll receive a validated certificate accredited with CPD/CEU credits and recognized by auditors.

Curriculum:

Introductory Video

Lesson 1: Packaging Components

Lesson 2: Regulatory and GMP Requirements

Lesson 3: Packaging Design and Artwork Management

Lesson 4: Packaging Process and Operations

Lesson 5: Testing and Evaluation of Packaging Materials

Lesson 6: Supplier and Quality Considerations

Conclusion

Evaluation