BS EN ISO 15378:2015

Comprehensive Standard for Primary Packaging Materials in Medicinal Products

BS EN ISO 15378:2015 is a critical standard for pharmaceutical companies and suppliers of primary packaging materials used in medicinal products. This standard, identical to ISO 15378:2015, provides comprehensive requirements and guidelines to ensure the quality, safety, and compliance of primary packaging materials.

Ensuring Quality and Compliance for Pharmaceutical Packaging

As a pharmaceutical manufacturer or supplier, compliance with this standard is essential to meet the stringent regulations governing the production and distribution of medicinal products. BS EN ISO 15378:2015 covers the following key aspects:• Company Organization and Management - Outlines requirements for the organizational structure, responsibilities, and management systems to ensure consistent quality and compliance.• Quality Administration - Specifies quality management system requirements, including documentation, change control, and continuous improvement processes.• Transport and Logistics - Provides guidelines for the handling, storage, and transportation of primary packaging materials to maintain product integrity.• Sociological Aspects - Addresses the human factors and ergonomics considerations in the design and use of primary packaging materials.

Comprehensive Requirements for Primary Packaging Materials

This standard is a valuable resource for pharmaceutical companies and suppliers, as it covers the full spectrum of requirements for primary packaging materials, including:• Material Composition and Properties - Specifies the physical, chemical, and biological properties of materials used in primary packaging, ensuring compatibility and safety.• Manufacturing and Production Processes - Outlines the necessary controls and validation procedures for the production of primary packaging materials.• Packaging Design and Development - Provides guidance on the design, testing, and validation of primary packaging to meet product and regulatory requirements.• Labeling and Traceability - Includes requirements for the identification, labeling, and traceability of primary packaging materials throughout the supply chain.

Compliance Benefits for Pharmaceutical Companies

By implementing the requirements of BS EN ISO 15378:2015, pharmaceutical companies and suppliers can enjoy the following benefits:• Improved Product Quality and Safety - Ensures the integrity and suitability of primary packaging materials for medicinal products, reducing the risk of contamination or product degradation.• Enhanced Regulatory Compliance - Demonstrates compliance with the latest industry standards and regulations, facilitating market access and regulatory approvals.• Streamlined Supply Chain Operations - Provides a common framework for managing primary packaging materials, improving efficiency and collaboration throughout the supply chain.• Competitive Advantage - Differentiates your company as a trusted supplier of high-quality primary packaging materials for the pharmaceutical industry.