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.
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.
Common examples of consumer complaints about drug products
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
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.
Common examples of how a lack in quality can affect company personnel