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Quality Management of Packaging Materials for Medicines and Medical Devices

The requirements of ISO 9001 are based on ‘PDCA’ approach – Plan, Do. Check and Act. The requirements are grouped on the basis that the manufacturer of packaging materials should have an organization to comply with the requirements of Quality Management, with commitment of top management. A clear quality Policy should be defined by the top management and communicated to all the personnel in the organization. Required resources in terms of production facility, quality systems, personnel, documentation, infrastructure should be provided by the top management. The customer focus is kept at the centre and all the support for planning and achieving quality objectives should be provided. The quality objectives and operational parameters should be measurable and the top management should provide adequate resources for measuring and monitoring the required parameters. The efficacy of the implementation of QMs should be reviewed by the top manage-ment at periodic intervals.

The essential requirements of ISO 9001 are:

• Understanding the needs and expectations of interested parties,
• Determining the scope of the quality management System
• Quality management system and its processes
• 5 Leadership
• 5.1 Leadership and commitment
• 5.1.2 Customer focus
• 5.2 Policy
• 6 Planning
• 6.1 Action to address risks and opportunities
• 6.2 Quality objectives and planning to achieve them
• 6.3 Planning of changes
• 7 Support
• 7.1 Resources
• 7.1.2 People
• 7.1.3 Infrastructure
• 7.1.4 Environment for the operation of processes
• 7.1.5 Monitoring and measuring resources
• 7.1.5.2 Measurement traceability
• 7.1.6 Organization knowledge
• 7.2 Competence
• 7.3 Awareness
• 7.4 communication
• 7.5 Documented information
• 8. Operation
• 8.1 Operational planning and control
• 8.2 Requirements for products and services
• 8.2.1 Customer communication
• 8.2.2 Determining the requirements for products and services
• 8.2.3 Review of the requirements for products and services
• 8.2.4 Changes to requirements for products and service
• 8.3 Design and development of products and services
• 8.4 Control of externally provided, products and services
• 8.5 Production and service provision
• 9 Performance evaluation
• 9.1.2 Customer satisfaction
• 9.1.3 Analysis and evaluation
• 9.2 Internal audit
• 9.3 Management review
• 10 Improvement
• 10.2 Nonconformity and corrective action
• 10.3 Continual improvement

The compliance to ISO 9001 emphasises estimation of risks of failures and appropriate corrective and preventive actions are taken in time so that products are safe and nonconformances are minimised and quality objectives are achieved.

Interface with Quality Management Systems – ISO 13485

ISO 13485 is quality management standard for medical devices. management standard for medical devices. The interface of quality management system with that of the manufacturers of the medical devices is highlighted in the following sections:

7.3 Design and development: The design and development of medical devices include designing, selection, development and use of appropriate packaging materials which will enable the design inputs and design outputs of medical devices are met to ensure the performance, efficacy, safety and reliability of medical devices.

7.4 Purchasing: This section outlines the requirements that the manufacturer of medical device shall comply with, to ensure the quality requirements of medical device. It is required that the medical devices manufacturer shall establish clear specification for the raw materials and packaging materials used in their product; shall procure materials only from approved suppliers; the supplied materials shall meet the requirements specified by the manufacturer of medical device; the performance of the suppliers of materials shall be evaluated on a periodic basis including vendor audits. Hence, it is important that the manufacturers