ISO 15378-2017 PDF

Full title and description

ISO 15378:2017 — Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP). The standard is an application of ISO 9001 tailored to suppliers and manufacturers of primary packaging materials intended to come into direct contact with medicinal products, adding GMP-related requirements relevant to that sector.

Abstract

ISO 15378:2017 specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide primary packaging materials for medicinal products that meet customer, statutory and regulatory requirements. It combines the requirements of ISO 9001:2015 with additional Good Manufacturing Practice (GMP) expectations applicable to primary packaging materials. The standard is intended for design, manufacture and supply of primary packaging for medicinal products.

General information

• Status: Published (confirmed current after systematic review).
• Publication date: 2017-09 (ISO 15378:2017).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 03.100.70; 11.040.01.
• Edition / version: Edition 4 (2017) — ISO 15378:2017; includes Amendment ISO 15378:2017/Amd 1:2024 (climate action changes).
• Number of pages: 79 pages.

Key bibliographic and lifecycle details above are recorded on the ISO catalogue entry for ISO 15378:2017.

Scope

ISO 15378:2017 is an application standard of ISO 9001:2015 for organisations involved in the design, manufacture and supply of primary packaging materials for medicinal products. It specifies both quality management system requirements and additional GMP-related requirements so that primary packaging materials consistently meet customer, regulatory and applicable international standards. The standard uses the phrase "if appropriate" in places where organizations may justify exclusion by documented rationale.

Key topics and requirements

• Application of ISO 9001:2015 clauses (context, leadership, planning, support, operation, performance evaluation, improvement) in the specific context of primary pharmaceutical packaging.
• GMP-related provisions addressing contamination control, traceability, handling, storage and clean conditions for materials that contact medicinal products.
• Requirements for documented information, control of records and evidence of conformity with regulatory and customer requirements.
• Supplier and subcontractor control, product identification and traceability through the supply chain.
• Design and development controls where applicable for packaging components, including verification/validation and risk considerations.
• Product release controls, nonconforming product handling, corrective and preventive actions, and continual improvement aligned with pharmaceutical expectations.

Typical use and users

Primary users are manufacturers, converters and suppliers of primary packaging materials for medicinal products (e.g., glass and plastic vials, ampoules, blister packs, bottles, closures, single-use containers, and labels). Other users include quality managers, regulatory affairs professionals, contract packagers, auditors, and certification bodies that assess conformity to ISO 15378 and related GMP expectations. The standard is used both as a requirements document for QMS implementation and as a basis for third‑party certification or internal compliance.

Related standards

ISO 15378 is built upon ISO 9001:2015 (quality management systems — requirements) and is intended to be applied alongside national and international GMP guidance (for example WHO GMP and regional GMP/regulatory requirements). It is also related to other sector management standards where integration is useful (e.g., ISO 14001 for environmental management) and to previous/superseded editions of ISO 15378.

Keywords

primary packaging, medicinal products, packaging materials, GMP, quality management system, ISO 9001:2015 application, traceability, contamination control, design control, supplier control, pharmaceutical packaging.

FAQ

Q: What is this standard?

A: ISO 15378:2017 is an ISO International Standard that specifies particular requirements for applying ISO 9001:2015 to organisations that design, manufacture or supply primary packaging materials for medicinal products, including GMP-related expectations.

Q: What does it cover?

A: It covers quality management system requirements (the structure and clauses of ISO 9001:2015) as they apply to primary pharmaceutical packaging, plus additional controls and practices to address contamination risk, traceability, product handling, documented evidence and other GMP-related areas.

Q: Who typically uses it?

A: Manufacturers and suppliers of primary packaging materials for medicines, contract packagers, quality and regulatory professionals in the pharmaceutical supply chain, and certification bodies performing audits/certification for ISO 15378.

Q: Is it current or superseded?

A: ISO 15378:2017 is the current published edition (Edition 4, published September 2017) and was confirmed in ISO's review process; it also has an Amendment (ISO 15378:2017/Amd 1:2024) addressing climate action changes. Older editions (2011, 2015) were superseded by the 2017 edition.

Q: Is it part of a series?

A: It is part of ISO's family of quality and sector application standards — specifically an application of ISO 9001 (quality management) for pharmaceutical primary packaging; it sits alongside other sector-specific QMS standards and guidance (and earlier editions of ISO 15378).

Q: What are the key keywords?

A: Primary packaging, medicinal products, GMP, ISO 9001 application, traceability, contamination control, quality management, supplier control.