Quality Management of Packaging Materials for Medicines
and Medical Devices
Dr. K. Sivakumar -
M. Pharm, Ph.D
Managing Director,
Pharmedices Technical Services |
Classification And Types Of
Packaging Materials, Quality Management Requirements,
Implementation Of Quality Management System In
Compliance With Requirements Of ISO 9001, Interface
With Quality Management Systems – ISO 13485, Special
Quality Management Standards, Quality Management
System For Primary Packaging Materials, Requirements
And Implementation Of Quality Management Standards.
Introduction :
Medical Devices are important
components in healthcare together with medicines,
medical care, nursing care and public health
programmes. The quality management of medicines and
medical devices are regulated by healthcare
regulations. |
In India, the regulations governing the
Quality Management of Medicines and Medical Devices by
Central Drugs Standards and Control Organization are
through Indian Drugs Cosmetics and Medical Devices Act and
Rules. The International Standards applicable for
Quality Management of medical devices are ISO 13485 and
the associated standards such as ISO 14971 on Risk
Management, ISO 10993 on Biocompatibility evaluations, ISO
14155 on Clinical Evaluations. There are other
international standards which are applicable depending on
nature of medical devices. The regulations in other
regional and national health care administrations are
European Medical Device Regulations, Quality systems
Regulations of USA, Medical Devices Regulations of Canada
etc.
Packaging materials are
integral part of medical devices and medicines, which are
packed in them. The packaging materials are quite a
constituent part of ensuring the efficacy, safety and
reliability of medicines and medical devices. The
packaging materials serve as containers and closures for
the medicine and medical devices, offer protection from
mechanical damage, environmental factors and ensure
stability of the medicine and medical devices contained in
them.
Therefore, it is
important that the packaging materials are designed,
manufactured and supplied to manufacturers of medicines
and medical devices according to well established quality
management systems and medicines and medical devices are
packed in them and processed as per the requirements. In
this article, an overview of the Quality Management
Systems applicable for packaging materials are described.
Classification and
types of packaging materials
The packaging materials
are made of a variety of materials, such as glass,
plastics, paper, laminates, rubber, other polymers and
composite materials. From the perspective of Quality
Management Systems, the packaging materials could be
classified as primary, secondary and tertiary packaging
materials. The primary packaging materials are those which
are in direct contact with the medical device or medicine
contained in them. Examples of primary packaging materials
are: containers such as plastic containers, bottles,
vials, ampuls, aluminium foils, foil laminates, paper
laminates, plastic laminates, pouches etc. When bottles or
vials are used, the corresponding closure systems also
form the primary packing materials. They perform the
functions of being the containers for the medicines and
medical devices, ensuring ease of administration as per
therapeutic indication, facilitating handling and
distribution of the contents in such way that the contents
are protected from environmental factors, contamination
including chemical, particulate and biological
contaminants, and ensuring stability of the contents. The
labelling information as per the regulatory requirements
are either printed or affixed as label on the primary
packing materials. It is important that the material and
design of primary packing materials are compatible with
the product contained in them, with respect to physical,
chemical and sterility requirements of the products. They
should be tamper proof and provide adequate protection
against misuse of and damage to the contents.
The secondary packaging
materials are those in which the medicines and medical
devices in their primary pack are assembled in number of
units appropriate for handling, storage and distribution
to wholesale, retail and individual users and customers.
They should have appropriate labeling information either
printed or affixed on them. They could be made of
cardboard and fibreboard, plastic containers or corrugated
boxes.
The tertiary packaging
materials are those in which the secondary packs are
assembled and shipped to destinations for further
distribution in supply chain. They are usually made of
corrugated boxes.
Quality Management
requirements for packaging materials:
The Quality Management
packaging materials is interrelated to the quality
management systems of medical devices and medicines which
are contained in them. The quality management systems
appropriate for packaging materials is ISO 9001 -Quality
management systems - Requirements, interface with ISO
13485 Medical devices — Quality management systems -
Requirements for regulatory purposes and in addition, for
primary packaging materials ISO 15378 Primary packaging
materials for medicinal products — Particular requirements
for the application of ISO 9001:2008, with reference to
Good Manufacturing Practice (GMP). In the following
sections of this article, essential principles of the
above standards are described.
Implementation of
Quality Management System in compliance with the
requirements of ISO 9001:
The manufacturers of
packaging materials are well recommended to have a quality
management system in compliance with the requirements of
ISO 9001: 2015. Though the compliance with the
requirements of ISO 9001 is a voluntary standard, most of
the manufacturers of medicines and medical devices expect
the suppliers of packaging materials to implement a QMS in
compliance with the requirements of ISO 9001. The
compliance is verified by the manufacturers of medicines
and medical devices by conducting audits of the
manufacturer of packaging materials and or requiring the
compliance to ISO 9001 be demonstrated by certification by
a certification body. It is important that the certifying
body be accredited to a national accreditation body,
because the certification by unaccredited body is not of
any recognition and does not add value to business by the
manufacturer of packaging materials.
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