Pharmaceutical Quality System
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1.5.2 Establish and Maintain a State of Control
To develop and use effective monitoring and control systems for process performance
and product quality, thereby providing assurance of continued suitability and
capability of processes. Quality risk management can be useful in identifying the
monitoring and control systems.
1.5.3 Facilitate Continual Improvement
To identify and implement appropriate product quality improvements, process
improvements, variability reduction, innovations and pharmaceutical quality system
enhancements, thereby increasing the ability to fulfil quality needs consistently.
Quality risk management can be useful for identifying and prioritising areas for
continual improvement.
1.6 Enablers: Knowledge Management and Quality Risk Management
Use of knowledge management and quality risk management will enable a company to
implement ICH Q10 effectively and successfully. These enablers will facilitate
achievement of the objectives described in Section 1.5 above by providing the means
for science and risk based decisions related to product quality.
1.6.1 Knowledge Management
Product and process knowledge should be managed from development through the
commercial life of the product up to and including product discontinuation. For
example, development activities using scientific approaches provide knowledge for
product and process understanding. Knowledge management is a systematic approach
to acquiring, analysing, storing and disseminating information related to products,
manufacturing processes and components. Sources of knowledge include, but are not
limited to prior knowledge (public domain or internally documented); pharmaceutical
development studies; technology transfer activities; process validation studies over
the product lifecycle; manufacturing experience; innovation; continual improvement;
and change management activities.
1.6.2 Quality Risk Management
Quality risk management is integral to an effective pharmaceutical quality system. It
can provide a proactive approach to identifying, scientifically evaluating and
controlling potential risks to quality. It facilitates continual improvement of process
performance and product quality throughout the product lifecycle. ICH Q9 provides
principles and examples of tools for quality risk management that can be applied to
different aspects of pharmaceutical quality.
1.7 Design and Content Considerations
(a) The design, organisation and documentation of the pharmaceutical quality
system should be well structured and clear to facilitate common understanding
and consistent application.
(b) The elements of ICH Q10 should be applied in a manner that is appropriate
and proportionate to each of the product lifecycle stages, recognising the
different goals and knowledge available for each stage.
(c) The size and complexity of the company’s activities should be taken into
consideration when developing a new pharmaceutical quality system or