The International Conference on Harmonization (ICH) draft guidance IVJ Q10 Pharmaceutical Quality System, which was released for public input, is the latest harmonization effort as it relates to the pharmaceutical industry's move
to a science and risk-based approach in pharmaceutical manufacturing.
Jason Kamm, managing consultant with Tunnell Consulting (King of Prussia, PA) discusses the challenges and opportunities for pharmaceutical manufacturers in implementing pharmaceutical
quality systems and ICH Q10 with Pharmaceutical Technology 's senior editor Patricia Van Arnum.
What would you identify as possible challenges and considerations for a pharmaceutical company trying to implement ICH Q10
as proposed or a pharmaceutical quality system in general?
Despite some of the obvious benefits that these harmonized guidances offer pharmaceutical manufacturers, these initiatives
have caught on slowly. We must remember that these guidances are all relatively new and that this industry has been notoriously
slow to adopt these types of changes. The possible reasons for this are many. Because these are guidance documents as opposed
to firm regulatory requirements, companies may feel little pressure to adopt them. Others may hesitate out of their traditional
concern about unnecessarily exposing previously "hidden" process vulnerabilities. Some organizations may lack skills that
are fully in tune with the requirements that these harmonized guidances involve.
The advantages, however, are attractive. These guidances offer a new paradigm that includes risk- and science-based approaches
to current good manufacturing practices (CGMP) that aim to manage variability through improved process understanding as opposed
to eliminating the variability. It also calls for identifying the areas of highest risk to the quality of the finished product
and selectively applies high levels of controls and effort to those areas only. It requires a rethinking of how process development
is done, integration of a new approach to validation, and a drive for continuous process improvement—all with the regulating
agencies envisioned as a partner in improving processes.
Quality systems in general are difficult and complex mechanisms that present challenges to implement. Companies that are tasked
with this effort typically have already been doing some activities that require at least the basic elements of a quality system.
These may include GMP manufacturing, some formalized training, and some may have even had an inspection by a regulatory agency.
The mistake some make is when they try to build a quality system "from scratch." This is often a problematic approach. The
most successful approaches involve respecting and honoring the past by flow-charting the processes of the existing quality
system. Only after this exercise is complete can a path be plotted for evolvement to a system such as ICH Q10 that is comprehensive
and built upon the sound principles of the sciencee- and risk-based approaches.
There are many examples of the industry trying to better understand their processes, which is a terrific first step. There
is still some hesitation related to how the regulating agencies will respond in practice. There is a great deal of faith involved
with implementing these systems, but I would stress that the focus of the faith should not be on how regulating agencies will
interact with these systems—the focus should be on the faith that these tools and this framework will provide the improvements
and change we wish to see.
What would you identify as the key components of ICH Q10 as a model for a pharmaceutical quality system?
The main moving parts of a quality system include areas such as the handling of deviations, corrective and preventive action
(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 key components, ICH Q10 also nicely 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. In addition, and perhaps more critically, continuous improvement allows for deeper process understanding
throughout the product life cycle.