ISO 15378 Certification

Ensure Pharmaceutical Packaging Safety with ISO 15378:2017

ISO 15378:2017 certification demonstrates your commitment to quality, safety, and compliance in pharmaceutical packaging. AGA Certifications offers internationally recognized ISO 15378 certification solutions tailored for manufacturers of primary packaging materials for medicinal products, helping businesses in UAE and beyond meet global GMP and regulatory benchmarks.

ISO 15378:2017 for Primary Packaging Materials

ISO 15378 integrates the principles of ISO 9001 and Good Manufacturing Practices (GMP). It provides a framework for managing production, control, storage, and distribution processes to ensure consistent quality, patient safety, and regulatory compliance in pharmaceutical packaging.

Benefits of ISO 15378:2017 Certification:

• Aligns operations with global GMP and ISO quality standards
• Improves safety and reliability of pharmaceutical packaging
• Reduces risks of contamination and non-compliance
• Demonstrates credibility with regulators and stakeholders
• Strengthens supply chain traceability and risk management

Core Focus Areas of ISO 15378

ISO 15378 emphasizes strict controls and monitoring to ensure safe and compliant packaging systems for medicinal products.

Key Implementation Areas:

• Quality Management: Documented QMS integrated with GMP practices
• Contamination Control: Clean environment, hygiene, and preventive systems
• Traceability: Lot coding, recall readiness, and supply chain visibility
• Risk Management: Proactive identification and mitigation of packaging risks
• Continuous Improvement: Ongoing evaluation and process enhancement

These requirements are supported by rigorous documentation and staff training to maintain compliance and safeguard product integrity.

Your Certification Partner in UAE

Why Choose AGA Certifications for ISO 15378?

• Proven expertise in pharmaceutical packaging certification
• Industry-specific guidance tailored to regulatory requirements
• End-to-end support—from gap analysis to certification
• Globally recognized audits and professional consulting
• Commitment to enhancing your compliance and market credibility

Our Tailored ISO 15378 Certification Services

We recognize that each business is unique. That’s why AGA offers customized solutions to meet your needs:

• Gap Analysis – Identify areas of improvement before the audit
• Staff Training – Equip teams with ISO 15378 knowledge and GMP practices
• Audit Support – Comprehensive assistance throughout certification
• Continuous Guidance – Stay updated with evolving global standards

Boost Your Brand with ISO 15378 Certification

Obtaining ISO 15378:2017 certification from AGA Certifications helps you:

• Enhance trust with pharmaceutical clients and regulators
• Meet global GMP and ISO quality requirements
• Improve safety, reliability, and risk management
• Achieve a competitive edge in international markets