ISO 15378:2015 Certification

ISO 15378:2015 certification is a globally recognized standard that merges ISO 9001:2015 with the GMP necessities relevant to primary packaging material. ISO 15378 specifies requirements for a quality management system where an organization necessities to demonstrate its capacity to supply primary packaging materials for medicinal products, which persistently meet client necessities, including regulatory requirements and International Standards applicable to primary packaging materials.

Why ISO 15378 Certification?

• Internationally known standard encompasses GMP necessities to primary packaging materials as well as ISO 9001 quality necessities;
• Enables companies to comply with legal necessities for pharmaceutical and medical device primary packaging materials;
• Mitigates risks of safety hazards and product contamination as well as make sure product efficiency and shelf life;
• Shows commitment to the health and well-being of those consuming medicinal products.

Benefits of ISO 15378 Certification

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