Primary Packaging Materials for Medicinal Products – ISO 15378

ISO 15378:2017 applies to all manufacturers of packaging materials that come into direct contact with the medical products. The standard covers all the typical materials, such as glass, rubber, aluminum, and plastics.

All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

It covers all GMP Principles (GMP = Good Manufacturing Practice), which are commonly used in the production of primary packaging materials.

This ISO standard is currently lined up with ISO 9001:2015 and has same 10 elements high-level structure. ISO 15378:2017 determines necessities for a quality management system where an association needs to exhibit its capacity to deliver primary packaging materials for medicinal products, which reliably meet customer requirements, including regulatory prerequisites and International Standards pertinent to primary packaging materials.

ISO 15378 Benefits

• ISO 15378 Standard has strategic tools that reduce costs by minimizing waste and manufacturing errors and increasing productivity.
• It encourages organizations to get to new markets and encourage free and reasonable worldwide exchange.
• The manufacturer can improve their proficiency of production processes by following GMP standards according to ISO 15378 standard.
• To relieve your risks particularly identified with product contamination, mix-ups and errors and ensure product efficacy and shelf life.
• Assurance of quality products to your clients. Upgrade customer satisfaction.
• Competitive Advantage over other non- confirmed providers.
• Application of risk management helps to reduce errors associated with the product.