A look at FDA GMP compliance

[Adam Fleming]

In a broad sense, GMPs refer to good manufacturing practices in any field. The main intention of these GMPs is that they enable industries to perform the required practices needed for complying with guidelines set out by the regulatory authorities. GMP guidelines are issued by regulatory authorities all around the world, mainly in the US, Canada, the countries of Europe and many others.

The ambit of the FDA GMP compliance covers FDA-regulated industries. This means that the FDA requires FDA-regulated industries to adhere to FDA GMP compliance. These FDA GMP compliance guidelines are not only stringent; they have the power of federal law, because these are mandated by the Federal Food, Drug, and Cosmetic Act, which established the FDA.

The rationale of FDA GMP compliance

FDA GMP compliance is built on the premise of requiring all entities that come under its ambit, such as those involved in the manufacture, processing, and packaging of medical devices, drugs and a few kinds of food, to implement best practices that are aimed at ensuring that the products they manufacture have safety, purity and effectiveness built into them.

These FDA GMP compliance regulations require the entities that come under their scope to approach manufacturing from a quality perspective, which these FDA GMP compliance requirements imbibe into them at every stage and process of manufacture. As a result, entities that are required to demonstrate FDA GMP compliance either eliminate or minimize all the undesirable side byproducts of manufacturing, such as adulteration, faults in the process, and contamination.

Consequences of failing to meet FDA GMP compliance guidelines

Since FDA GMP compliance guidelines are deemed as having the equivalence of law; manufacturers and other entities that are required to show FDA GMP compliance can attract severe penalties in the event of failure to take steps to implement FDA GMP compliance guidelines.

Some of the consequences of failure to implement FDA GMP compliance include the following:

• Recall
• Seizure
• Fines
• Imprisonment

What issues do the FDA GMP compliance regulations address?

FDA GMP compliance guidelines address issues of GMP that make a difference to the manufacturing process. These include:

Use your common sense, the FDA says

The major highlight of these FDA GMP compliance requirements is that they are seldom set in stone. The FDA has deliberately left these GMP requirements broad and general, in view of the fact that each manufacturing unit has its own unique needs. These GMP guidelines are just those - guidelines - and need to be adapted by companies based on their needs and requirements.

The manufacturer is expected to show a level of discretion. In effect, the FDA GMP compliance requirements need to be implemented in such a manner that the manufacturer should be able to explain the rationale for his practices to the FDA in a convincing manner.