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Quality Management of Packaging Materials for Medicines
and Medical Devices
of packaging materials
should comply with quality management systems and supply
materials of consistent quality to the manufacturers of
medical devices. The medical device manufacturers are
required to clearly specify the quality specifications of
packaging materials and the manufacturers of packaging
materials should comply with them. The conformance to the
specifications shall be verified by the manufacturers of
medical devices.
7.5.9 Traceability: It
is the requirement that the manufacturers of medical
devices establish and implement procedures for
traceability of devices manufactured and the components
used in them, including packaging materials. Therefore,
the requirement of traceability is established in
manufacture of packaging materials as well, so that the
same could be linked to the traceability of medical
devices.
In addition, the
sections on labelling, control of nonconformance,
measurement, internal audit and improvement also have
impact on the quality of packaging materials and the
manufacturers of packaging materials.
Special quality
management standards for packaging materials.
In addition to the
general quality management standards described as above,
there are specific quality management standards for
primary packaging materials and packaging materials for
sterile medical devices.
The quality management
system for primary packaging materials
The quality management
system for primary packaging materials is given in ISO
15378.
ISO 15378 is a special
standard for application of ISO 9001 and principles of
Good Manufacturing Practices. The primary packaging
materials are those which come in direct contact with the
medicines and medical devices and include the primary
container and closure systems. The essential requirements
of ISO 15378 are derived considering the principle that
the primary packaging material should be manufactured with
compliance to quality requirements similar to that of
medicines and medical devices. It is an international
standard comprehensively addressing the principles of Good
Manufacturing Practices, Quality Management Systems for
medical devices, Risk Management and requirements for
sterile medicinal products. It underpins the relationship
between the manufacturer of packaging materials and
manufacturer of medicinal products as operating on a
technical agreement for overall compliance of medicinal
products to quality specifications.
The essential
principles of ISO 15378 are:
• 4.1.1 Risk management
• 6.2.2.1 GMP training
• 6.3 Infrastructure
• 6.4.1 Work environment requirements
• 7.3.7.1 Notification
• 7.3.7.2 Design change
• 7.5.1.1 Cleanliness of product and contamination control
• 7.5.1.2 Segregation controls
• 7.5.1.3 Change control
• 7.5.1.4 Particular requirements for sterile primary
packaging materials
• 7.5.3 Identification and traceability
• 8.2.4.1 Investigation of OOS results (Out Of
Specification)
• 8.2.4.4 Batch release
• 8.2.4.5 Retained samples
• 8.2.4.6 Production and control data.
ISO 15378 also has
annexes describing the requirements of printed primary
packaging materials, validation and risk management.
The compliance to the
requirements of ISO 15378 is currently voluntary. However,
many leading manufacturers of pharmaceuticals and medical
devices, use the equirements of this standard in their
technical agreements with the suppliers of packaging
materials and while during supplier evaluation and vendor
audits. Hence, the manufacturers of primary packaging
materials are recommended to implement the quality
management system and get it certified by any accredited
certifying body.
Packaging materials
for sterile products
The quality
requirements of selection and use of appropriate packaging
materials for sterile medicals are given ISO 11607-1
Packaging for Terminally Sterilized Medical Devices – Part
1: Requirements for materials, sterile barrier systems and
packaging systems.
Requirements and
implementation of quality management Standards for
packaging materials
The details of the
requirements of the standards outlined above and
guidelines for implementation of such quality management
systems will be described in the subsequent parts of the
series of articles on this subject, to be published in the
future editions of this publication.
References:
i) ISO 9001 -Quality management systems - Requirements,
ii) ISO 13485 - Medical devices — Quality management
systems — Requirements for regulatory purposes
iii) ISO 15378- Primary packaging materials for medicinal
products — Particular requirements for the application of
ISO 9001:2008, with reference to Good Manufacturing
Practice (GMP).
iv) ISO 11607-1 Packaging for Terminally Sterilized
Medical Devices – Part 1: Requirements for materials,
sterile barrier systems and packaging systems.
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