Current Good Manufacturing Practices (CGMPs)
US FDA regulations that guide the design, monitoring, and maintenance of manufacturing facilities and processes
What is Current Good Manufacturing Practices (CGMPs)?
Current Good Manufacturing Practices (CGMPs) refers to the regulations provided by the US Food and Drug Administration (FDA) that guide the design, monitoring, and maintenance of manufacturing facilities and processes. The FDA enforces the regulations to ensure that manufacturing facilities of pharmaceutical products, medical devices, food and beverages, and dietary supplements are in good condition, the equipment is well maintained and calibrated, and the employees are well trained and qualified to handle the manufacturing equipment and processes.
The CGMPs guidelines ensure that the identity, strength, quality, and purity of food and pharmaceutical products have been tested to meet the minimum requirements set by the FDA.
What is the Code of Federal Regulation (CFR)?
The Code of Federal REgulation (CFR) is an arrangement of the permanent regulations of the federal government. It is divided into 50 titles, according to the areas under federal government regulation. In each of the titles, there are several chapters that are assigned to various federal agencies that issue rules and regulations regarding a specific subject area.
Each chapter is categorized into several parts according to specific regulatory areas. Each part is divided into sections, which is the basic unit of the CFR. Citations to the CFR usually refer to specific information at the section level.
The Office of the Federal Register maintains an online version of the CFR, which is updated at least two days after changes have been published in the Federal Register. The online CFR is available for public access, and it is a joint project by the publisher, the Office of the Federal Register, the National Archives and Records Administration, and the Government Publishing Office. The online-CFR an unofficial version of the CFR.
Non-Compliance with CGMP Regulations
If the FDA conducts an inspection on a manufacturing facility and finds the manufacturer non-compliant, any drugs or food products produced in the facility are considered adulterated. This does not necessarily mean that there is something wrong with the drug, but it means that the manufacturing process of the drug did not comply with Current Good Manufacturing Practices regulations. The FDA issues Form 483 to the manufacturer, requiring them to respond with a detailed explanation and the corrective action that they plan to take.
If the drug in question is already in the hands of the public, then the FDA advises consumers to continue using the drug, since stopping taking the drug may negatively impact their health.
Instead, patients are advised to seek advice from their personal physician on whether they should change their medication or stop the medication entirely. The FDA action will rarely stop the distribution or manufacturing of a drug unless the drug is contaminated or unsafe for human consumption. The action taken depends on the drug and the nature of violations.
CGMP In the United States
CGMP regulations in the United States are governed by statute and by agency policies, which monitor and control the manufacturing facilities and processes. The FDA is required to oversee the compliance of food and pharmaceutical manufacturers by ensuring that the items manufactured meet specific requirements such as identity, quality, strength, and purity. The word “current” in the term means that food and drug manufacturers must use the latest technologies and do away with obsolete technologies.
In response to government regulations, some drug manufacturers now implement internal risk management systems. Compliance with Current Good Manufacturing Practices also requires manufacturers to establish operating procedures, use high-quality raw materials, maintain reliable product testing laboratories, and investigate any reported product quality issues.
The FDA can conduct random or planned inspections of any pharmaceutical manufacturing facility to verify their compliance with CGMP regulations. Also, the inspections can be triggered by industry events or reports of drug contamination.
How FDA Ensures Compliance with CGMP Regulations
One of the roles of the FDA is to ensure uniformity across all pharmaceutical products distributed in the market. Drug manufacturing companies must comply with CGMP guidelines to ensure that the drugs released to the market are of high quality and safe for consumers.
The FDA achieves its objectives by carrying out inspections of active ingredients, as well as of finished products. The inspections are carried out by highly trained staff, who may rely on reports of potentially defective drugs to conduct impromptu visits to manufacturing plants.
Importance of CGMPs
Current Good Manufacturing Practices provide guidance to pharmaceutical companies to help ensure that their finished products are safe for human consumption. In normal cases, a person cannot tell whether a product is safe or not through touch, smell, or sight. Also, a person may not be able to tell whether the active ingredients indicated on the label are actually what’s in the drug.
By conducting lab testing and random inspection of manufacturing facilities, the FDA aims to ensure that drugs produced in the market are safe for human consumptions and that the recommended manufacturing guidelines are followed.
Additional Resources
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