In the pharmaceutical and medical device industry, ISO 15378 is a critical certification for manufacturers of primary packaging materials (such as glass, rubber, and plastics). This standard integrates Good Manufacturing Practices (GMP) with ISO 9001 requirements to ensure compliance with regulatory and quality standards.
🔍 Why is ISO 15378 Important?
✅ Ensures compliance with global regulatory requirements (FDA, EMA, WHO).
✅ Reduces risks of contamination and enhances patient safety.
✅ Improves traceability and documentation for audits and inspections.
✅ Enhances operational efficiency and reduces defects.
📊 Market Trends & Compliance Insights
The global pharmaceutical packaging market is projected to grow from $107 billion (2024) to $163 billion by 2030, driven by stringent quality regulations.
Non-compliance with packaging standards has led to 40% of drug recalls in recent years.
📉 Common Challenges in Certification
🚨 Lack of GMP-compliant processes
🚨 Inadequate risk management & traceability
🚨 Documentation gaps & audit failures
📈 How Ecoverix Solutions Helps You Achieve ISO 15378
🔹 Gap Analysis – Identifying compliance gaps in current packaging operations
🔹 Process Optimization – Implementing risk-based quality control measures
🔹 Training & Awareness – Conducting GMP & ISO 15378 training for teams
🔹 Documentation Support – Assisting in SOPs, validation protocols & audits
🔹 Internal Audit & Readiness Check – Ensuring a smooth certification process
💡 Achieve Compliance with Confidence!
Partner with Ecoverix Solutions to streamline your ISO 15378 certification journey and enhance your packaging quality.
📩 Connect with us today!
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