Costs of Failure in Product Quality

The authors detail the possible consequences of noncompliance and a lack of quality control.
Apr 02, 2012
Volume 36, Issue 4

Advances have been made in the understanding and effective handling of quality issues in the manufacture of pharmaceutical products in the past decade. Sources of quality deficiencies are largely a result of manufacturing processes that lack sufficient risk mitigation, intended and unintended changes in process, inadequately planned equipment budgeting, changes in quality of active and inactive ingredients or their suppliers, and human error. All factors, individually or together, may result in variability in quality, even in routinely manufactured products.

Understanding the major sources of variation is essential to the design and control of robust processes. Over time, a component of a process may drift from its target because of intrinsic or extrinsic factors. These factors may be either unknown initially or considered to be insignificant during development and manufacturing.

Pharmaceutical manufacturing companies must be prepared to face internal and external audits and, most importantly, withstand rigorous regulatory audits without notice. Often a firm will use audits to gather information to correct unknown errors and shortcomings in routine operations to meet cGMP requirements. It is possible, however, that even with careful monitoring and good training, deficiencies in products may occur due to changing regulatory requirements, unknown ingredient changes, modifications in process, equipment changes, increased scientific awareness, and unintended employee negligence. A pharmaceutical manufacturer that lacks quality control may face difficult regulatory issues with unpleasant ramifications, including recalls and FDA Warning Letters. This article highlights some of the key issues that may impact a company that does not ensure quality.

Consumer safety

Common examples of consumer complaints about drug products
Product safety is a key focus of all regulatory agencies and drug manufacturers. All drug products must conform to approved or established standards of quality, be safe and effective, and be manufactured according to cGMP requirements per FDA mandate. All lots of drug products released by a company must meet all FDA-approved specifications and standards as well as company requirements, and be supported by required data and proper documentation. Failure to meet a specification of a marketed drug product must be reported to the regulatory agencies promptly and corrective and preventive actions must be initiated immediately.

Complaints by wholesalers, distributors, pharmacies, or consumers often occur upon noticing products with faulty appearance. Such a product may be defective and result in unnecessary adverse reactions and inadequate efficacy that may lead to direct risk to the well being of the consumer. The obvious inadequacy of the product could be due to one of many reasons (e.g., inadequate formulation characterization or optimization, change in grade of active or inactive ingredients, foreign contaminants, inadequate packaging or manufacturing controls, poor maintenance, manufacturing process changes, and packaging issues such as faulty containerclosure system).

Common examples of how a lack in quality can affect company personnel
Poor quality in pharmaceuticals is often not visible or otherwise obvious to the consumer, so the quality control and quality assurance (QA) activities performed by the manufacturer are crucial. All products must be manufactured under strict cGMP guidelines and require extensive controls and testing prior to release of the product. Extensive testing is necessary to determine if a product is defective. When a quality issue is suspected at any time, there must be proper investigations, root-cause analyses, and action plans to address issues (1). In addition, if the products do not meet specifications, all affected lots of the drug products must be recalled from distribution after informing FDA and other regulatory agencies. Lots that have not been distributed should be quarantined to prevent distribution.

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