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
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Accuprec Research Labs Pvt. Ltd., India |
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KLJ
Group, India |
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Ltd. |
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Pashiba Lifescience, India |
Plastivision India |
Pradeep Surgipack, India |
PVC Colouring Compounding & Processing,
India |
Qosina,
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SMC Medical Manufacturing Pvt. Ltd.,
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Twist Engineering Works,India |
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China |
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Angiplast Pvt. Ltd., India |
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Jain Rubbers Pvt. Ltd., India |
Operon Strategist, India |
R.R. Patel Gases (P) Ltd., India |
Proven Trade Contacts, India
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Sanidhya
Enterprise, India |
Surgi Pack India Pvt. Ltd. |
Unikal Consultants, India |
Vinit Performance Polymers Pvt. Ltd., India |
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Pvt. Ltd., India |
Angel Products, India |
Apex Medical Devices, India |
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Kavya Packaging, India |
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Mesco Surgical, India |
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National Healthcare, India |
Pharmadocx, Inida |
S. Nath & Co., India |
Unikal Consultants, India |
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Zinkal Products, India |
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