SOPs and Quality Controls
Companies use Standard Operating Procedures (SOPs) to help their businesses run smoothly and consistently. FDA expects companies to use SOPs to comply with certain FDA requirements. FDA will review SOPs as part of their inspection or audit process and could issue Form 483s and Warning Letters that cite specifics about a company’s SOPs if they are found to be inadequate. Recall plans are another example of an SOP.
There are legal mandates to have documentation of procedures and corrective actions for many FDA-regulated products, which we discuss below. However, SOPs are not just for meeting legal requirements – every procedure should accomplish something, such as serving as a guide to help keep foods from becoming adulterated or getting illegal colorants out of a cosmetic.
SOPs are useful for specific situations, for example, an SOP regarding import delays (part of an import manual) may describe common problems and how to respond and include a guide for what to ask FDA and when, etc. Also, it’s important to keep in mind that procedures need to have a reasonable chance of being fully followed. In other words, companies must actually be able to implement them.
Food | Standard Operating Procedures
SOPs are critical components of any food safety program. FDA’s Food Safety Modernization Act (FSMA) calls for several plans as part of their requirements. FDA’s Hazard Analysis and Risk-Based Preventive Controls regulation calls for food safety plans. These plans help companies identify food safety issues related to the physical plant, existing procedures, or personnel issues.
Also, as part of FSMA, importers have SOP requirements under the Foreign Supplier Verification Program (FSVP) rule. They must create and maintain plans documenting the verification of their foreign suppliers’ compliance with food safety standards. FDA conducts FSVP inspections of importers and will issue warning letters if there is no plan or if it is inadequate. Even if an on-site facility inspection isn’t held, FDA may conduct a remote inspection of the plan.
We have the experience to develop and evaluate your compliance plans and are ready to assist any international or domestic food companies developing and implementing FSMA-critical food safety plans.
Drugs | Good Manufacturing Practices
Drug requirements around SOPs mainly focus on FDA’s Current Good Manufacturing Practice (CGMP) regulations. If manufacturers fail to comply with FDA’s drug GMPs then the manufactured drugs are considered adulterated. FDA often seizes drugs that were manufactured out of drug GMP compliance. CGMP regulations include requirements around methods, facilities and controls used, with the goal of making sure products are safe, meet ingredient and strength claims, and include directions for use and warnings.
Our team has extensive expertise and experience in applying FDA’s drug GMP regulation requirements for finished drug manufacturers, sterile drug manufacturing, and API manufacturers. We can assist with audits of drug manufacturing facilities to ensure pending FDA inspections are successful.
Medical Devices | Quality System Regulations
Most medical devices must be manufactured in accordance with FDA’s Quality System Regulations (QSRs). The QSRs represent the GMP program FDA implements for medical devices in the United States, and they are the closest of all of FDA’s GMP regulations to the more internationally recognized International Standards Organization (ISO) process. SOPs are also commonly used for device complaint handling.
With our former FDA medical device facility inspectors and compliance officers, we can evaluate your SOPs, quality polices, and manufacturing records to ensure compliance with FDA’s QSRs.
Dietary Supplements | Good Manufacturing Practices
The Dietary Supplement Health and Education Act (DSHEA) gives FDA express statutory authority to prescribe current good manufacturing practice (GMP) regulations for dietary supplement manufacturers and distributors. As a result, FDA has established dietary supplement GMP regulations which now apply to practically every dietary supplement manufacturer and distributor to one degree or another. The FDA dietary supplement GMPs are a kind of combination between the agency’s regulation of conventional food and drug products.
Manufacturers and distributors are expected to ensure the safety of their products before marketing them in the United States and must also make certain the products are properly labeled with truthful and non-misleading information. One of the key FDA regulatory requirements relating to dietary supplement safety and truthfulness in labeling and marketing involves manufacturing and distributing dietary supplements in accordance with FDA’s dietary supplement GMP regulations.
We provide you with clear, insightful, and actionable information to ensure compliance with dietary supplement labeling CGMP requirements.