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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.

Many companies in either new/emerging markets, or startup organizations may be

familiar with the scientific aspects of product/process development but not the de-
tails of quality management and the roles that management and operational groups
play. In addition an appreciation of the details of regulatory protocols underlying
GMP, ISO 9000:2015, and the need for careful documentation to support process
validation and equipment qualification may be beyond their experience. Even es-
tablished organizations often overlook all of the elements of the audit process, and
how auditors are increasingly looking at systems.

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.

“Compliance is an affirmative indication or judgement that the supplier of a product

or service has met the requirements of the relevant specifications, contract or regula-
tion; also the state of meeting the requirements. Compliance is something that meets
both the text and the spirit of a requirement.”

“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:

. Systems-Based Audits and Inspections

. Defining Metrics
. Risk Based Approach to Quality Auditing
. Auditor Techniques
. Documentation and Reporting Techniques
. Computerized Systems Audits and Data Integrity Requirements

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Each point is developed in detail, together with practical examples and applicable
regulations in the new book. The latter point has become an area of increasing at-
tention and comment by the U.S. Food and Drug Administration as well as instru-
ment suppliers and software vendors.

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.

A well-designed and thorough audit and control program is both an asset to a

company’s reputation and business prospects, and a means of protecting products
and patient safety. Without those internal protections you risk the consequences of
putting contaminated or ineffective treatments into the healthcare system.

About the Authors:

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.


To learn more about DHI, or to schedule interview with Amy Davis, please e-mail You can also check out the DHI website at DHIbooks.