Quality Progress - January 2014 - 64
ONE GOOD IDEA
BY JOHN G. SUEDBECK
Categorize and control your risk management audit data
ICH Q9 IS a U.S. Food and Drug Adminis-
supplier evaluation, recalls, returns,
tration standard on quality risk management
complaints, deviations, out of specifica-
developed by the International Conference
tion results, internal audits, noncon-
inspections. List all evaluations and re-
on Harmonization of Technical Require-
formances, change control, validation,
evaluations. Include distributors because
ments for Registration of Pharmaceuticals
documentation, calibration and preven-
they are part of the pedigree (an audit
for Human Use. "Quality Risk Management"
tive maintenance, product testing crite-
trail that follows a drug from the time it
from Annex II provides guidance for manag-
ria and finished goods release. Review
is manufactured through the distribution
ing risk and lists risk factors to help auditors
define the frequency and scope of audits.1
for adequacy and compliance.
* Complexity of the site and distribu-
* Results of previous audits and
system to a pharmacy).
* Major changes related to build-
Auditors collect evidence during the
tion. Review general site information,
ing, equipment, processes and key
audit process and sort evidence according
pest control, holding and distribution
personnel. Review the organization's
to the appropriate risk factor to facilitate
risk assessment mitigation planning. I like
controls and security.
* Complexity of the manufacturing
history and change notification records.
* Experience with the manufacturing
to think of the factors provided in ICH Q9
process. Perform process mapping and
of a product. This may include fre-
as "risk buckets" for sorting data.
trace the supply chain. Identify key steps
quency, volume, number of batches and
in the process. Verify there are adequate
the percentage of the organization in the
controls in place for each key step. Iden-
pharmaceutical industry. The robustness
tify and define quality filters in place (a
of their quality management system and
safeguard analysis that shows what risks
the level of technology in use also may
are managed and how).
* Complexity of the product and its
serve as evidence of their experience.
* Test results of official laboratories.
therapeutic significance. In descending
Review pass and release testing results
order of risk, review sterile finished prod-
and regulatory history.
ucts, nonsterile finished products, sterile
A plethora of evidence often is obtained
Note that reasonable conclusions are
active pharmaceutical ingredients (API),
from the audit process and it can become
based on evidence that is sufficient, reliable
nonsterile APIs with special risk factors
confusing trying to make sense of it all. The
and relevant. Previously, I discussed the
(such as isomerisim, polymorphism or a
risk factors suggested in ICH Q9 provide a
reliability of audit evidence in "Solid Proof"
special risk of harmful impurities), labs
means of sorting the data into manageable
(June 2012).2 The following is an approach
and contract research organizations, non-
buckets that can help your organization as-
for determining the relevancy of audit
sterile APIs, excipients, labels and product
sess risk and manage it effectively. QP
evidence as it pertains to each of the risk
factors in ICH Q9:
* Existing legal requirements. Review
Also consider risk factors associated
with solubility, fermentation, toxicity,
nondisclosure agreements, supply agree-
synthesis, impurities, solvents, chemical
ments and quality agreements.
activity, potency and particle size:
* Overall compliance status and his-
* Number and significance of qual-
tory of the organization or facility.
ity defects. This is the quality history
Review regulatory status certifications
review for the item or service. Consider
and customer audit history.
the development history as well. Review
* Robustness of an organization's
recalls, returns, complaints, deviations,
quality risk management activities.
out of specification results, internal audit
Verify controls are in place for training,
data, nonconformances and internal
64 QP * www.qualityprogress.com
REFERENCE AND NOTE
1. Access ICH Q9 at www.fda.gov/downloads/
2. John G. Suedbeck, "Solid Proof," Quality Progress, June 2012,
JOHN G. SUEDBECK is a quality
assurance specialist for Metrics Inc.
in Greenville, NC. He earned a bachelor's degree in analytical chemistry
from Fayetteville State University in
North Carolina. A senior member of
ASQ, Suedbeck is an ASQ-certified
quality manager, quality improvement
associate and quality auditor.
Table of Contents for the Digital Edition of Quality Progress - January 2014
Mr. Pareto Head
Breaking Down Barriers
Follow the Fundamentals
Back in Service
Quality in the First Person
One Good Idea
Quality Progress - January 2014