ISO 15378 Quality Assurance
Quality assurance: ISO 15378 Primary packaging materials for medicinal products particular requirements for the application of ISO 9001:2008, with reference to GMP.
ISO 15378 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meets customer requirements, including regulatory requirements & international standards applicable to primary packaging materials.
Operon Strategist helps manufacturers develop their quality management system as per the requirements of ISO 15378. We help in documentation, training & implementation of the quality system.
We are assisting to Manufacturer of Primary packaging material to understand the requirements of ISO 15378 by performing a GAP analysis, and implementing QMS and GMP requirements as per ISO 15378:2015.
We are supporting to manufacturers of primary packaging materials for the medicinal product to enhance their QMS system by addressing specific requirements to meet the quality objectives as per ISO 15378. We assist the pharmaceutical and medical device industries to assess their suppliers of primary packaging materials and increase overall product quality.
What is ISO 15378
We also conduct mock internal quality audits to help clients familiarize with the audit process. We guide the client through the audit process & subsequently also help them close any non-conformances observed during the audit.
ISO 15378:2011 specifies requirements for a quality management system for medical device primary packaging materials and manufacturers of pharmaceutical.
These organizations need to demonstrate their ability to consistently meet customer requirements, including regulatory requirements and international standards applicable to primary packaging materials for such medicinal products.
The standard delineates GMP principles and specifies QMS requirements applicable to primary packaging materials for medicinal products.