ANSI - American National Standards Institute
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Drug Recall Underscores Value of Risk Assessment

New York, Nov 10, 2006

Roughly eleven million bottles of the commonly used pain reliever acetaminophen are under recall after an internal quality control check at a major generic drug manufacturer turned up tiny metal fragments in a number of the company’s 500-milligram caplets. The recall affects more than 380 lots of acetaminophen distributed and sold under various store-brands, some as long as three years ago. Both the manufacturer and the U.S. Food and Drug Administration (FDA) are investigating the cause of the metal particles, which were first found when the manufacturer discovered that its tableting equipment was wearing down prematurely.

Safety hazards can arise at many points during the manufacturing life cycle. Identifying potential hazards, assessing risk and employing appropriate countermeasures is an important component to any manufacturing process, particularly so where products for human consumption are involved. The effects of contaminants in over-the-counter medications and other consumer products require testing, evaluation and analysis to assess health and environmental consequences.

Risk assessment services can be used to optimize the manufacturing process so as to develop safer healthcare products and minimize risks to human health and the environment. As an example, ANSI accredited standards developer NSF International (NSF) and its research and consulting company Global Lifescience Solutions (GLS) have developed a number of human health and environmental health risk assessments for use by government and industry.

NSF and GLS risk management services for the healthcare industry encompass over-the-counter medications, prescription drug and biological products. The programs’ vendor support services include exposure assessment, contaminant testing and product label reviews, in addition to claims verification and substantiation. Risk assessments conducted by GLS have been used to support government petitions for new product approvals, in litigation to characterize risks, and by others to establish due diligence.

Assessing the risks posed by manufacturing equipment is also an important element of the manufacturing process. Taking into account factors such as equipment condition and productivity, a machine’s design and its intended use, risk assessment of machinery helps to ensure safety and minimize variation in machine performance. Because modifications to machinery can introduce new hazards, risk assessment of upgraded equipment is also regarded a key factor to safe manufacturing.

Guidance for performing risk assessment of machinery is provided in the international standard ISO 14121:1999, Safety of Machinery - Principles of Risk Assessment. The standard was developed by the International Organization for Standardization’s technical committee 199, safety of machinery, and can be applied to a wide range of industry settings. The standard gives guidance on the information required to identify hazards and evaluate risk; its procedures pertain to all phases of the life of the machinery.

Further information about the acetaminophen recall can be found on FDA’s website.

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