ISO 15378 – Quality Management System in Pharmaceutical Packaging Industry

Quality Management System in
Pharmaceutical Packaging Industry according to ISO 15378

ISO 15378 is an international quality management system standard specifically for primary packaging materials for medicinal products, combining ISO 9001 (quality management systems) with pharmaceutical GMP (Good Manufacturing Practices) requirements.

Key benefits of
ISO 15378 and Pharmaceutical GMP

Enhanced Product Quality

Ensures consistent, contamination-free packaging materials that meet stringent pharmaceutical quality and safety standards.

Regulatory Compliance

Aligns with global GMP and ISO requirements, simplifying audits and ensuring faster regulatory approvals.

Risk Management

Identifies and controls manufacturing risks, minimizing product defects and ensuring process stability.

Customer Confidence

Demonstrates commitment to quality and compliance, strengthening confidence among pharmaceutical clients and partners.

Operational Efficiency

Promotes documentation, traceability, and continuous improvement, optimizing production performance and reducing operational waste.

How to establish the quality management system in pharmaceutical packaging Industry according to ISO 15378?
Establishing ISO 15378 — the international standard for Primary Packaging Materials for Medicinal Products, which integrates ISO 9001 with GMP (Good Manufacturing Practices) — involves several key steps:
1. Understand the Standard Requirements
  Review ISO 15378 to understand its scope, which includes quality management, GMP principles, risk management, traceability, and regulatory compliance for packaging materials.
2. Top Management Commitment
  Secure leadership support to provide resources, define quality objectives, and promote a culture of compliance.
3. Develop or Update QMS (Quality Management System)
  Document and align policies, SOPs, work instructions, risk management protocols, and traceability procedures with ISO 15378.
4. Train Employees
  Educate staff on ISO 15378 requirements, GMP principles, hygiene practices, and quality roles.
5. Implement GMP-Compliant Practices
  Ensure production, cleanliness, labeling, storage, and documentation meet GMP standards.
6. Internal Audits and Corrective Actions
  Conduct audits to verify compliance; address non-conformities with root cause analysis and corrective actions.
7. Management Review
  Hold formal reviews to assess the QMS effectiveness, audit results, KPIs, and opportunities for improvement.
8. Certification Audit by Accredited Body
  Select an ISO-accredited certification body to conduct the external audit for ISO 15378 compliance.
9. Continual Improvement
  After certification, maintain and improve the QMS through regular audits, reviews, and updates.