ISO 15378 identifies the requirements for a quality management system that identifies the principles of good manufacturing practice (GMP) and is applicable to primary packaging materials for pharmaceuticals.

 

The realization of the GMP principle in the production and management of primary packaging materials within an organization is crucial to the safety of patients using the drug because of direct product contact.

 

 

 

 

• This International Standard specifies the requirements for a quality management system when it is necessary for an organization to demonstrate the organization's ability to provide primary packaging materials for medicines.
  The requirements are those that consistently meet consumer requirements, including international standards and regulations applicable to primary packaging materials.
• This international standard applies to the design, manufacture and supply of primary packaging materials for pharmaceuticals.
  This specification may also be applied for authentication purposes.
• All requirements of this standard are generic and developed to be applicable to all organizations regardless of form, size and product offered.
• It may be possible to consider excluding any requirements of this International Standard that can not be applied due to the nature of the organization and its products