EN ISO 15378:2017 PDF

Overview

EN ISO 15378:2017 (ISO 15378:2017) specifies quality management system requirements for organizations that design, manufacture and supply primary packaging materials for medicinal products. It is an application of ISO 9001:2015 with additional Good Manufacturing Practice (GMP)-related requirements to ensure packaging consistently meets customer, statutory and regulatory requirements. The standard helps demonstrate product conformity, maintain traceability and support regulatory compliance for pharmaceutical packaging.

Key topics and technical requirements

• Application of ISO 9001:2015 principles tailored to primary pharmaceutical packaging, including leadership, planning, support, operation and performance evaluation.
• GMP-related controls integrated into the QMS to address risks specific to medicinal-product packaging.
• Design and development controls for primary packaging materials, including planning, inputs, outputs and change management.
• Control of externally provided processes, products and services (supplier qualification and oversight).
• Production and service provision requirements covering operational planning, identification and traceability, preservation and post-delivery activities.
• Resources and competence, including personnel, infrastructure, monitoring and measuring resources and GMP training.
• Documented information and IT administration to control quality records and data integrity.
• Risk-based approach and the expectation that requirements qualified by “if appropriate” are treated as applicable unless the organization documents justification otherwise.

Practical applications

• Establishing a compliant quality management system for manufacturers of vials, closures, blister packs, syringes, bottles and other primary packaging components intended for medicinal products.
• Supporting regulatory submissions and supplier qualification by demonstrating consistent control of materials that contact medicines.
• Integrating supplier controls and traceability into procurement and production workflows to reduce contamination and recall risk.
• Serving as the basis for internal and external audits, continuous improvement programs and GMP training plans.

Who should use ISO 15378

• Manufacturers and suppliers of primary packaging materials for medicinal products
• Quality, regulatory and compliance teams in pharmaceutical packaging supply chains
• Contract manufacturers and converters providing packaging components for drug products
• Auditors and certification bodies assessing QMS conformance to pharmaceutical packaging requirements

Related standards

• ISO 9001:2015 - foundational QMS requirements incorporated into ISO 15378
• Applicable national and international GMP regulations and guidance (as required by regulators)

Keywords: ISO 15378, primary packaging materials, GMP, ISO 9001:2015, pharmaceutical packaging, quality management system, traceability, supplier control.