The Key Focus Points And Documents Required For Iso 15378 Standard

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ISO 15378 specifies the quality management system criteria for pharmaceutical and medical device primary packaging manufacturers, as well as their ability to consistently offer safe and trustworthy packaging. Aluminum, containers/components, films, foils, glass, laminate containers, plastics, and rubber are among the packaging materials that come into direct contact with pharmaceutical items. Suppliers of pharmaceutical primary packaging must demonstrate the quality of their manufacturing process by using a quality management system (QMS) and good manufacturing practices (GMP).

ISO 15378 incorporates ISO 9001 requirements as well as specific Good Manufacturing Practice principles (GMP). It also enables the manufacturer to regulate product efficacy and quality while reducing product contamination and eliminating safety hazard challenges. An ISO 15378-certified quality management system (QMS) indicates the capacity to meet the customer's expectations, regulatory requirements, and applicable international standards consistently.

The ISO 15378:2017 standard specifies rules for the design, development, production, and ...
... distribution of packaging materials for pharmaceutical items such as containers, closures, and labels. The standard also contains risk management, quality control, and documentation requirements. Pharmaceutical packaging standards, such as ISO 15378:2017, are essential for ensuring that packaging materials meet the requirements for the safe and effective storage, transportation, and use of pharmaceutical medicines. These guidelines address a wide range of pharmaceutical packaging concerns, including

• Quality management system for packaging materials
• Risk management for pharmaceutical packaging
• Contamination control for medicinal product packaging
• Supply chain management for packaging materials
• Traceability of pharmaceutical packaging
• Quality control for packaging materials in the pharmaceutical business

ISO 15378:2017 establishes requirements for primary packaging material manufacturers' quality management systems (QMS), including

1. Management responsibilities: The standard defines senior management's duties and responsibilities in establishing and maintaining the QMS.
2. Resource management: The standard specifies procedures for managing resources such as staff, infrastructure, and equipment.
3. Product realization: The standard specifies the criteria for ensuring that packaging materials are manufactured by client specifications and regulatory requirements.
4. Measurement, analysis, and improvement: The standard specifies procedures for monitoring and measuring the effectiveness of the QMS, as well as for continual development.

The ISO 15378:2017 Standard includes strategic solutions for lowering costs by reducing waste and manufacturing errors and enhancing efficiency. Standard encourages businesses to enter new markets and promotes open and reasonable global trade. The manufacturer can improve their production processes by adhering to GMP standards as defined by the ISO 15378:2017 certification requirement. To reduce the risks, particularly those related to product contamination, mix-ups, and errors, as well as to assure product efficacy and shelf life. The standard also ensures that customers receive high-quality products. Improve customer satisfaction and competitive advantage over other providers. The use of risk management aids in the reduction of product-related errors.

What are the ISO 15378 Implementation focus points?
• Integration of customer requirements for key packaging materials for pharmaceutical items
• Simplifying and standardizing manufacturing and other business processes
• Control and monitoring of manufacturing processes
• Contingency planning and risk management
• Quality Policy and Objectives Development
• Establishing a system for keeping ISO 15378 documents and record updated
• System of management information
• Business performance and long-term viability

What are the documents required for ISO 15378 registration?
By preserving, establishing, implementing, and presenting documented information, the organization will demonstrate continuous development in the field of quality management systems. The documentation needed for ISO registration

• organization’s scope
• organization’s quality policy and quality objectives
• Quality Manual
• Standard Operating Procedures
• Records at specific process/department
• Declaration, Maintenance, and Customer Service