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ISO 15378:2017

Primary packaging materials for medicinal products ISO 15378:2017 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. All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. In ISO 15378:2017 the term "if appropriate" is used several times. When a requirement is qualified by this phrase, it is deemed to be "appropriate" unless the organization can document a justification otherwise. ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.

Benefits of certification:

- Helps pharmaceutical organizations minimize, or eliminate, contamination, mixing and manufacturing errors.

- Provide guidance on risk management and verification.

- Improve the efficiency and cost effectiveness of business operations.

- Continuously meet customer requirements, including regulatory requirements.

- Competitive advantage.

The ISO 15378 standard has been developed to provide quality management systems (QMS) to drug suppliers that pharmaceutical stakeholders want to use as pharmaceutical packaging. This process-oriented ISO 15378 standard, published for the first time in 2006, is a single document related to the design, manufacture and supply of basic packaging materials for GMP (Good Manufacturing Practice Principles of Good Manufacturing Practice) . Medicinal products. The application of the GMP Principles provides confidence that pharmaceutical packaging meets regulatory and pharmaceutical industry requirements.

ISO 15378 specifies the requirements for QMS to demonstrate the ability to consistently deliver primary packaging for pharmaceuticals. In addition to the requirements contained in ISO 9001: 2000/2008, ISO 15378 applies to key packaging areas such as unique additional requirements risk management, batch / lot traceability, verification of critical processes and environmental controls.

Obtaining certification for this standard further assures you of a good quality product. By being certified for this standard, organizations can also achieve quality goals and objectives and continually improve manufacturing processes.

- Compliance with legal requirements

- identification, reduction and control of risks, including contamination and manufacturing errors; improved efficiency and cost effectiveness in operations

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