"Q10 covers the life cycle from development to the termination of the product," explains Famulare. "All of the elements in
ICH Q8 and ICH Q9 fall under this quality-system umbrella, which needs to be threaded and implemented throughout the life
cycle." For example, the quality system provides firms the ability to mange within the design space as described in ICH Q8.
The document is consistent with the elements of ICH Q7 applying to active pharmaceutical ingredients, notes Famulare.
"Q10 pulls all of these ideas together into process and product realization over the life cycle of the product. It provides
for the utilization of knowledge over the commercial life cycle to serve as a means of continual improvement and back to development
where this knowledge can be used for future development," says Famulare.
The players in the International Conference on Harmonization
The systems approach presented in ICH Q10 has a common theme with ICH Q8 and ICH Q9 in that it is centered on a science-
and risk-based model, explains Jason Kamm, managing consultant at Tunnell Consulting (King of Prussia, PA).
"The ICH Q8 guidance on product development helps define the activities a company must show to demonstrate they understand
their manufacturing processes and that proper controls are in place—the basic elements of the science-based approach," says
Kamm. "Changes can therefore be made autonomously without previous approval of a regulating agency (inside the design space)
based on demonstrated knowledge or understanding of the product or process. Since product development is an element of the
product life cycle, ICH Q10's linkage to ICH Q8, which establishes the building blocks of the science-based approach, is clear."
ICH Q10 also complements the quality risk-management concepts embodied in ICH Q9. "The ICH Q9 guidance on the risk-based approach
helps define the activities a company may take based on the use of risk management," says Kamm. These activities relate to
items such as changes, release tests, and process controls and monitoring. "Throughout the product life cycle, whenever decisions
are made, risk must first be identified, and systems must be in place to adequately control them," he says. "This allows for
a departure from the mechanical nature of compliance in the past. Activities can be prioritized based on risk; more time is
spent on areas of high risk, and less time is spent on areas of lower risk."
Kamm explains the main moving parts of a quality system include the handling of deviations, CAPA, release systems, and process
monitoring and controls. These components rely on two concepts that are a common theme throughout ICH Q10: continuous improvement
and the management of change resulting from these improvements. "ICH Q10 makes it clear that these elements apply not only
to the product throughout its life cycle, but also to the quality system itself."
In addition to these components, ICH Q10 also defines the product life cycle to include product development, technology
transfer, manufacturing and product discontinuation. "Continuous improvement involves elements such as cost savings, streamlining,
and elimination of waste," says Kamm. "In addition, and perhaps more critically, continuous improvement allows for deeper
process understanding throughout the product life cycle."
ICH Q10 and quality systems
The underlying principles of the pharmaceutical quality system in ICH Q10 are consistent with the effort by FDA when issuing
its 2006 guidance on quality systems (5). That guidance was intended to help manufacturers implement modern quality systems
and risk-management approaches to meet the requirements of the agency's CGMP regulations (5).