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The benefits of implementing Good Manufacturing
Practices and quality management are henceforth made easier
to achieve for the pharmaceutical sector thanks to a new standard
from ISO (International Organization for Standardization).
"The standard is of vital importance to the pharmaceutical
industry and its suppliers of pharmaceutical primary packaging
materials. For the first time, the principles of Good Manufacturing
Practice are specified as part of an ISO standard," explained
Dr. Jürgen Thürk, Convenor of the working group
that developed the new standard. |
"The standard is of vital importance to the pharmaceutical
industry and its suppliers of pharmaceutical primary packaging materials.
For the first time, the principles of Good Manufacturing Practice
are specified as part of an ISO standard," explained Dr. Jürgen
Thürk, Convenor of the working group that developed the new
standard.
Good Manufacturing Practices (GMP) relate to quality control and
quality assurance enabling companies in the pharmaceutical sector
to minimize or eliminate instances of contamination, mix-ups, and
errors. This in turn, protects the customer from purchasing a product
which is ineffective or even dangerous. Up until now, however, there
was no applicable guideline or rule for primary packaging materials,
which contain, seal or are used for dose application and have direct
contact with the medicinal product.
The publication of ISO 15378:2006, Primary packaging materials
for medicinal products – Particular requirements for the application
of ISO 9001:2000, represents an international consensus on good
practice and establishes a benchmark that can be applied for quality
improvement, training, auditing and certification.
Developed with the participation of pharmaceutical sector experts,
ISO 15378:2006 incorporates in a single document the quality management
requirements of ISO 9001:2000 together with the Principles of Good
Manufacturing Practice (GMP) for the design, manufacturing and supply
of primary packaging materials for medicinal products.
In addition, the new standard
gives guidance on risk management and validation and –
in line with current developments worldwide – contains
guidance annexes on both these aspects.
The standard is applicable to all primary packaging materials
(glass, rubber, plastic, aluminum, etc.).
ISO 15378:2006 was developed by ISO technical committee ISO/TC
76, Transfusion, infusion and injection equipment for medical
and pharmaceutical use. The standard costs 154 Swiss francs
and is available from ISO national member institutes (see
the complete list with contact details) and from ISO Central
Secretariat (see below).
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From www.iso.ch
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