What is ISO 15378 Certification?

ISO 15378 is an international standard that specifies requirements for the design, manufacture, and supply of primary packaging materials for medicinal products. It focuses on the management of product quality, hygiene, and risk management processes in the pharmaceutical industry supply chain.

ISO 15378 certification ensures that the pharmaceutical packaging materials are of high quality and comply with international regulations, reducing the risk of product recalls and ensuring patient safety. The standard covers a range of requirements, including good manufacturing practices, quality management systems, and product traceability.

Organizations that obtain ISO 15378 certification demonstrate their commitment to producing high-quality pharmaceutical products, improving customer satisfaction, and complying with industry regulations. The certification can also help organizations to differentiate themselves from competitors and increase their market share.

Achieve ISO 15378 Certification with Greenstitch Advisor – A Reliable Partner for Your Pharmaceutical Packaging Quality Management System

At Greenstitch Advisor, we provide ISO 15378 Certification services to pharmaceutical packaging material manufacturers. The ISO 15378 standard provides guidelines for the implementation of a Quality Management System (QMS) for the design, development, production, installation, and servicing of primary packaging materials for medicinal products.

By obtaining the ISO 15378 certification, pharmaceutical packaging material manufacturers can demonstrate their commitment to quality and compliance with regulatory requirements. The certification also helps in improving operational efficiency and reducing costs by identifying and eliminating non-conformances in the production process.

Our team of experienced ISO 15378 consultants helps organizations in implementing the standard by providing guidance on documentation, training, and internal auditing. We ensure that the certification process is smooth and hassle-free, and our clients receive their certification in a timely manner.