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Robust Quality Audits Are The Solution To Avoiding Expensive Recalls
Robust Quality Audits Are The Solution To Avoiding Expensive Recalls
Robust Quality Audits Are The Solution To Avoiding Expensive Recalls
Tim Sandle
Recent pharmaceutical product recalls have pointed out the need for effective qual-
ity management systems that include robust audit facilities. The lack of effective
audits, quality management systems (QMS), and in some cases malicious activity
have compromised product quality and in turn, patient safety, resulting in several
widely used medications being recalled.
While these aspects may be viewed as management overhead by some, used prop-
erly, audits and controls are an effective defense of product and production quality
as well as a demonstration of control over manufacturing processes. This will help
ensure customer satisfaction and patient safety, avoiding the consequences of prob-
lems uncovered during inspections that could have been detected and corrected
by in-house oversight. As noted in the new book “Audit and Control for Health-
care Manufacturers” by Tim and Jennifer Sandle (published by DHI, http://www.
dhibooks.com/books/17351.html):
“If designed and implemented appropriately, audits can provide valuable information
for prevention of issues.”
The goal is to catch problems before they impact product quality, and putting pa-
tients at risk. In addition to the regulations noted, the following points will con-
tribute to an effective audit/control program:
Those who are concerned with the cost of compliance programs need to consider
the ramifications of compliance failures that include expensive recall programs, the
damage done to a company’s reputation, and the prospects for future business de-
velopment. A sound compliance program is an asset for a well-managed organiza-
tion, and the basis for continual process improvement. The benefits of quality and
compliance audits extend to and evaluation of your suppliers including vendors,
contract manufacturers and key third-party partners as noted in the book. They
can prevent out-of-specification materials, data, and equipment from contaminat-
ing a manufacturing process and causing products to fall out-of-specification.
Dr. Tim Sandle, Head of Microbiology and Sterility Assurance at Bio Products
Laboratory, UK, has over 25 years experience of microbiological research and
biopharmaceutical processing. In addition, he is a visiting tutor with the School of
Pharmacy and Pharmaceutical Sciences, University of Manchester.
Jennifer Sandle is an experienced auditor of quality systems (GMP and ISO 9001),
laboratory operations, and, the Quality Assurance Manager at the National Insti-
tute of Biological Standards and Control, which is part of the U.K. Medicines and
Healthcare products Regulatory Agency.
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To learn more about DHI, or to schedule interview with Amy Davis, please e-mail
amydavis@dhibooks.com. You can also check out the DHI website at DHIbooks.
com.