ICH Q9 provides guidance for quality risk management in the pharmaceutical industry. It encourages companies to implement quality by design from development through production to build quality into their processes and products. This helps reduce risks and allows for more efficient monitoring. While some companies fear changing processes may not be understood by FDA inspectors, proper documentation of scientific rationale is important. Strategies that mitigate multiple risks at once can help address areas of highest risk while supporting FDA compliance and inspection. ICH Q9 aims to foster both efficient operations and regulatory compliance in the competitive pharmaceutical industry.

1. Risk Management:
Applying ICHQ9 to the
Pharmaceutical Business
Since the late 1970s, the pharmaceutical industry UNDERSTANDING ICHQ9 Pharmaceutical Technology Institute at Xavier
has been looking for guidance. Before they can In Nov. 2005, ICH issued a document to guide University. “They’re trying to prepare for when the
release new drugs to consumers, these companies Quality Risk Management (ICHQ9). Historically, FDA walks through their doors.”
need to know how to maintain compliance with companies have prepared for FDA inspections by However, the FDA is encouraging companies to
somewhat vague regulations from the FDA. But in reviewing their competitor’s FDA reports to find focus on their internal processes and systems in
an increasingly competitive landscape, they also out what the FDA is evaluating. order to:
need to know how to succeed as a business. “They try to adjust their procedures, their prac- • Build quality into the process and product
Rather than asking the FDA to update their tices and their systems to fall in alignment with (known as “Quality by Design” or “QbD”) from
regulations, The International Conference on what they’re hearing that the FDA is interested in,” the development stages forward, rather than
Harmonisation of Technical Requirements for says Marla Philips, PhD and director of the waiting until the end of production to test the
Registration of Pharmaceuticals for Human Use
quality of the product.
(ICH) gathered input from experts within the
industry. Through a series of documents, ICH can • Reduce overall risk and implement continuous
help these companies understand how FDA regula- QbD monitoring to ensure their risk strategy’s
tions fit within the business of pharmaceuticals.
ICH can help companies effectiveness and to prevent the introduction
of new risks.
These documents allow companies to learn from
each other, maintain compliance based on avail-
understand how FDA
• Improve antiquated processes and analytical
able company resources, and evaluate their current
processes with a clearer understanding of FDA reg-
regulations fit within the methods in order to improve consistency of
quality, which may lead to a more efficient—
ulations. pharmaceutical business. and therefore more cost-effective—process.
The Xavier Leadership Center, Exponent 8 Fall 2008

2. MITIGATING RISK CONCERNS ABOUT APPLYING Q9
“The safest way [to mitigate risk and maintain
There’s a need to not Since most FDA inspectors do not have industry
compliance],” according to Philips, “is to stick
with something the FDA is comfortable with. If
only deliver a product experience, some companies are afraid to change
from an existing process to one that—while scien-
they come in and see a process they’re not com- that’s effective, but also tifically equivalent—may not be easily understood
fortable with, your product may not be approved. by inspectors who lack the experience to under-
And every day that it’s not approved is big money to be more efficient. stand the scientific justification. But many compa-
lost.” nies do not sufficiently document scientific
For the sake of ensuring FDA compliance and rationale and justification. Without this documen-
mitigating risk, companies are encouraged to ana- tation, they cannot maintain GMP compliance and
lyze their existing systems, evaluate risks within DEVELOPING STRATEGIES inspectors cannot determine if the rationale is sci-
those systems and assign resources to address entifically sound.
Some QRM strategies may help to mitigate numer-
those risks. “[ICHQ9] is not new information in general, but
ous risks at once. “When you develop a strategy
“[The FDA has] inspectors who’ve been in the it’s important to the FDA regulators and to the
for one risk,” notes Philips, “it could mitigate
industry for years,” says Philips, “and they might overall pharmaceutical industry. If the FDA can
another. Think through proactively. Ask yourself
go in and be looking for these same [old process- inspect more companies with fewer inspectors, and
what’s involved?
es] and not be comfortable trying to understand if technically advanced processes can be made
If you change one thing, how does it cascade
the scientific justification [of the new process].” more efficient, then prescription drug costs can go
through? Or if you cover another risk more
Both the companies and the inspectors want to down. And by instituting QbD, consumers can still
intensely, what other risks are covered?” As you
maintain existing processes that have been shown have safe and effective drugs.”
develop QRM strategies, focus your resources on
to support compliance and have been historically
areas of highest risk. And as you apply ICHQ9 to
accepted by FDA inspectors. But in a competitive
your business, make sure you can help FDA inspec-
industry, these standard processes may not be
tors understand and accept your QRM processes.
enough.
STAYING COMPETITIVE AND COMPLIANT
Understanding that companies need to make a
profit while staying compliant, the FDA issued
High
“cGMPs for the 21st Century” to address current
good manufacturing practices in the pharmaceuti-
cal industry. Through this document, the FDA is
driving efficiencies in the operation of a pharma-
ceutical business while fostering compliance with
Mitigate Avoid
FDA regulations. According to Philips, there’s a
Probability
need to “not only deliver a product that’s effec-
tive, but also to be more efficient. Because when
we don’t, people are paying more money for their
prescriptions and the government is getting a lot
of flack for that. These political pressures are part
of [the FDA’s] drive to focus on risk management.”
It’s also a question of available resources. The
FDA doesn’t have enough inspectors to evaluate
every company, not only within the United States
but internationally as well. With many pharmaceu-
tical companies outsourcing various parts of their Accept Transfer
operation, the FDA has to make strategic decisions
about which sites to evaluate. “They’ll generally
look at sites involved with making sterile prod-
Low
ucts,” says Philips. “They don’t have the resources
to inspect all the companies, but they hold the
parent companies responsible for compliance of all
these companies [they outsource to].”
Low High
Impact
Managing multiple risks requires a strategy that considers the probability and impact of the risk, as well as the
detectability of the event. Companies should focus resources on risks that have high probability and high
impact, while maintaining an effective continuous monitoring system to monitor all identified risks.
Are you interested in learning more about risk
management in the pharmaceutical industry?
Visit www.xavier.edu/xlc to learn more about Xavier Leadership Center’s Pharmaceutical Technology Institute today.
The Xavier Leadership Center, Exponent 9 Fall 2008