More than 70 years ago the U.S. Congress gave the FDA regulatory authority to create manufacturing processes that would apply to pharmaceutical companies, vitamin and supplement manufacturers, and even food producers. The idea behind the legislation was to ensure American consumers had access to safe products. GMP manufacturing has been a huge success; so much so that most of the rest of the world has adopted similar practices.
When the regulatory agencies or manufacturers use the designation cGMP they are referring to the most current incarnation of the given regulations. That makes sense given the fact that the “C” stands for the word “current.” Manufactures following cGMP regulations are up to date and using the best practices for their particular industry. But what about those companies not up to standard? How is cGMP enforced?
Regulatory Enforcement in the United States
Enforcement of cGMP manufacturing in this country is the domain of the FDA. On occasion they employ other agencies to help with enforcement efforts when needed. Their primary enforcement tools include annual, announced inspections and routine unannounced inspections. They announced inspections are usually just a formality in light of the fact that the company knows inspectors are on their way. It is the unannounced inspections that really keep companies in line.
According to the law the FDA, or one of its authorized agencies, can walk in on any manufacturing company without warning. However, federal courts have consistently ruled that unannounced inspections can only take place during routine business hours. That means pharmaceutical and food companies must always be on the ready for an Inspector who could show up on any day of the workweek. If violations are found a manufacturer is cited and given so much time for corrective action. Fines will also be assessed as appropriate. Continual failure to comply could result in seizure of a company and prosecution of those responsible.
Regulatory Enforcement around the World
Around the rest of the world cGMP manufacturing standards are nearly identical to what we have in the States. Likewise, so are the enforcement options. Inspectors conduct both scheduled and unscheduled inspections, write up citations and corrective actions, and punish offenders through fines, seizures, and criminal prosecutions. About the only thing different on an international scale are the agencies responsible for enforcing the regulations.
In the European Union that authority belongs to the National Regulatory Agencies. In the United Kingdom the Medicines and Healthcare Products Regulatory Agency has jurisdiction. Some of the other participating nations are as follows:
- Australia – Therapeutical Goods Administration (TGA)
- Brazil – National Health Surveillance Agency
- South Africa – Medicines Control Council (MCC)
- South Korea – Korea Food & Drug Administration (KFDA)
There are other enforcement agencies around the world with jurisdiction over cGMP manufacturing. We’ve only provided a few here because they are too numerous to list them all. Suffice it to say the diligent monitoring of manufacturers ensures consumers continue to have access to safe products from both domestic and international companies.