ANAB has launched an accreditation program for certification bodies that wish to offer certification for ISO 15378, Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP).
The ISO 15378 standard specifies requirements for organizations to demonstrate their ability to provide primary packaging materials for medicinal products that consistently meet customer and regulatory requirements.
According to ISO, the standard “specifies requirements for a quality management system when an organization: (a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements and (b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.”
ISO 15378 requirements are generic and are applicable to any organization, regardless of type or size or the products and services it provides.
ISO notes that in this standard, the terms “product” or “service” apply only to products and services intended for or required by a customer. It’s also noted that statutory and regulatory requirements can be expressed as legal requirements.
The term “if appropriate” appears several times in ISO 15378. Requirements qualified by this term are deemed appropriate unless the organization can document a justification otherwise.
Certification for ISO 15378 allows an organization to mitigate risk – especially as it relates to contamination and errors – and to ensure customers that its quality management system is in compliance.
ISO 15378 includes QMS guidelines for primary manufacturers of glass, plastic, rubber, aluminum and other materials used for medicinal packaging, including compliance with legal requirements; identification, reduction, and control of risks including contamination and manufacturing errors; and improved efficiency and cost-effectiveness of operations.
