News

Your ISO 15378 Certified Pharmaceutical Packaging Manufacturer

2026-07-16

What does ISO 15378:2017 Certification mean for Our clients

We’re proud to announce that our company has achieved ISO 15378:2017 certification, an internationally recognised standard for manufacturers of primary packaging materials for medicinal products that combines the general principles of ISO 9001 Quality Management with the Good Manufacturing Practice (GMP) requirements expected within the pharmaceutical industry.

Here is what obtaining this certificate means in practice.

Rigorous Quality Management

Every stage of production is monitored through documented quality assurance and quality control processes. From incoming raw materials to final inspection, quality is built into every step.

Controlled Manufacturing Processes

Changes to materials, equipment, or manufacturing methods are carefully evaluated through formal change control procedures and risk assessments before implementation.

Skilled and Trained Employees

Our team receives ongoing training not only in their specific roles but also in GMP principles, ensuring everyone understands how their work contributes to the safety and quality of pharmaceutical packaging.

Equipment Qualification and Process Validation

We carry out qualifications and validations to confirm proper equipment functionality and process execution, ensuring the resulting product meets all specifications.

Hygiene and Contamination Control

Maintaining clean production environments and robust contamination controls is essential when manufacturing packaging intended for pharmaceutical applications.

Complete Traceability

The implemented system guarantees traceability at every stage of production, thereby enabling tracking from raw material to finished product and from finished product to raw material.

A Commitment to Continuous Improvement

ISO 15378 also embraces the principles of current Good Manufacturing Practice (cGMP), recognising that quality is an ongoing journey rather than a one-time achievement.

We continually review our processes, invest in improvements, and adopt best practices to ensure we meet the evolving expectations of the pharmaceutical industry. This is also a reflection of our company’s long-term commitment to excellence. We will continue investing in our people, our processes, and our manufacturing capabilities to ensure we remain a trusted partner to customers operating in highly regulated industries.

We thank our employees, customers, and partners for their continued support as we build on this achievement.