Every year, the US Food and Drug Administration issues scores of Warning Letters to pharmaceutical, medical device, and biologics companies. Although Warning Letters can be triggered by situations such as customer complaints and whistleblower statements, the majority follow an inadequate company response to a Form 483 issued by FDA after an on-site inspection has identified potential violations of regulatory requirements.
SOPs and QualityThe purpose of an SOP is straightforward: to ensure that essential job tasks are performed correctly, consistently, and in conformance with internally approved procedures. Clearly, employees' correct, consistent performance of essential job tasks is as much a business and quality issue as it is a regulatory requirement.
Few industries are more vulnerable to risk than the life sciences sector. Although all industries share a financial vulnerability resulting from operational inefficiency, the liability associated with compromised product quality can hit a life sciences company particularly hard. Compromised product quality can easily result in product recalls, regulatory enforcement, and governmental litigation, but even the suspicion of quality problems can send patient, healthcare professional, and stakeholder confidence plunging. With highly publicized product recalls still fresh in the minds of the public and regulators, life sciences companies and their products are coming under greater scrutiny than ever before. And, because FDA's Warning Letters are public information, public scrutiny is quickly fueled by news reports via the media or the Internet.
Although FDA has long emphasized the importance of SOP compliance, the Agency's evolving focus on quality as the driver of compliance adds weight to the importance of a comprehensive corporate approach to development and use of SOPs. Warning Letters routinely conclude with a sober reminder that "... violations may result in FDA taking regulatory action without further notice to you." FDA has an arsenal of actions it can impose, from confiscating product inventory to initiating product recalls, assessing civil penalties and fines, or pursuing criminal prosecution.
FDA's definition of an SOP is deceptively simple. SOPs are, according to a variety of FDA regulations, written procedures that accurately describe and detail essential job tasks. For example, in 21 CFR 211.100, the regulation states: "There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit."
Beyond the written procedure, SOP compliance includes a requirement to train employees on essential job tasks, something expressed in 21 CFR 211.25, which applies directly to the pharmaceutical industry, but is applicable to all life sciences industries. "Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, experience, or any combination thereof to enable that person to perform the assigned function." It is this combination of written procedure and employee training that assures the quality of a drug product or medical device being tested or manufactured and its compliance with applicable FDA regulations.