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
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 container–closure system).