ISO 15378 GMP For Pharma Packaging Materials
- • ISO 15378 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
- • 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 meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials....
- What is primary packaging material?
- - Primary packaging is the packaging in direct contact with the product itself and is sometimes referred to as consumer or retail packaging. The main purpose of primary packaging is to protect and/or preserve, contain and inform the consumer.
- - Materials for primary packaging are an important risk factor in pharmaceutical production processes since they are in direct contact with the product and must be considered a key raw material, so their origin and suppliers must be strictly controlled. The ISO 15378 standard is designed to be an international standard of the quality system for allowing Organizations to show their capacity of supplying primary packaging materials for pharmaceutical products, which comply strictly with regulatory requirements and the requirements of Clients, as well as with international practices.
- WHAT ARE THE BENEFITS OF ISO 15378?
- - Risk management: the ISO 15378 standard certification is designed to help organizations to identify, control and manage risks.
- - Demonstrates good quality, manufacturing and safety controls.
- - Aligns with the ISO 9001 standard that allows certified companies to optimize implementing the requirements of the ISO 9001 standard.
- - Protects the brand and its image, both publicly as well as with the key interested parties.
- - Regulatory compliance: the 15378 standard supports the efforts of the Organization to meet regulatory and legal requirements.
- - Client satisfaction: it is designed to improve client satisfaction, including the processes for continuous improvement and the guarantee of compliance with the client's requirements.
- - Ensure compliance with the principles of Goof Manufacturing Practices for primary product packaging of medicines.
- At TMC, we have more than two decade helping companies that work in regulatory sectors to optimize their processes and ensure regulatory compliance. Contact and get the advice you need to implement and certify ISO 15378.
