ISO 15378:2017 Certification Quality Management System for Primary Packaging Materials

Overview

ISO 15378:2017 certification ensures that organizations consistently produce safe, high-quality packaging materials for medicinal products while complying with international regulatory standards. It strengthens quality, safety, and regulatory compliance across the supply chain.

Why ISO 15378 Certification Matters

• Ensure consistent quality and safety of primary packaging materials
• Comply with international regulations like FDA, EMA, and WHO GMP
• Enhance customer confidence and brand credibility in the pharmaceutical industry
• Reduce risks of contamination and product recalls
• Improve operational efficiency, traceability, and process control
• Gain access to global pharmaceutical markets

Who Can Be Certified?

• Bottles, vials, ampoules, and blister packs
• Caps, closures, and droppers for medicinal products
• Tubes, sachets, and pouches for pharmaceuticals
• Labels and inserts in contact with medicinal products
• Any other primary packaging material for human or veterinary pharmaceuticals

Key Requirements

• Integration of ISO 9001:2015 QMS principles
• Compliance with Good Manufacturing Practices (GMP)
• Management responsibility and leadership commitment
• Resource management and personnel competence
• Product realization and process validation
• Risk management and control of critical production processes
• Supplier evaluation and procurement controls
• Monitoring, measurement, and traceability of materials
• Control of nonconforming products
• Corrective and preventive actions (CAPA) and continual improvement

Benefits of Certification

• Globally recognized QMS for primary packaging materials
• Improved product safety, reliability, and compliance
• Reduced risk of contamination and recalls
• Enhanced customer trust and market reputation
• Operational efficiency and strengthened process control
• Facilitates export and global market access

Certification Process

1. Submit application and define scope of packaging materials
2. Optional gap analysis and implementation support
3. Stage 1 audit – documentation review and readiness assessment
4. Stage 2 audit – on-site assessment of QMS and GMP compliance
5. Certificate issuance by PSA Quality Certification Limited or associated agencies
6. Periodic surveillance audits to maintain continual compliance