Have you ever seen a GMP approved drug or pharmaceutical label?  Do you really know what this means? Well, GMP stands for good manufacturing practices.  It means that the product has passed certain guidelines proving the safety and efficacy of the product.  These GMPs are legal regulations that are established by the United States Food, Drug, and Cosmetic Act.  They are put in place to protect the consumer by making sure that companies are releasing safe and efficient products.

Why Are GMPs Important?

Most people ask themselves, “Why do companies need to be regulated by GMPs?  Shouldn’t a knowledgeable company be able to figure out how to create a product or device that is safe and effective?”   Well, the truth of the matter is that the answer to that question is both yes and no. Companies are by all means knowledgeable, but they do need their work to be properly monitored.  There are rules for everything in life and there is a reason for that. It keeps everything organized and structured.  Without rules and regulations, companies would create their own standards and consumers would be left unprotected.  That being said, most people turn to these products because they are supposed to promote wellness.  If these products are produced with impurities they can become a risk for the consumer.

How Does The FDA Make Sure Companies Are Following GMP Regulations?

With so many companies spread throughout the United States, how is it possible that the FDA can regulate all of them?  Well, the FDA inspects pharmaceutical manufacturing facilities worldwide.  They even inspect the facilities that manufacture the active ingredients that were used in the final products.  For instance, the FDA will not only inspect your pharmaceutical company, but they will inspect the companies that are producing your ingredients.  Inspections usually are approached in a standard manner.

That being said, the FDA does rely greatly on reports of potentially defective drugs from the public and others in the industry.  When the FDA receives a report that a company might be producing an impure or defective product, they will use these reports to incite an inspection on that facility.  It should be noted, under normal conditions, most companies that are inspected are usually found to be fully compliant with all GMP regulations.  So, how exactly does a company make sure that it is GMP compliant and what kind of regulations do they need to follow?

Proper Documentation

In order for a company to be GMP compliant they are going to need to document all their practices.  Every activity within the company needs to be recorded.  Documents and records should be controlled and listed in a filing system with track document numbers, latest versions, issue dates, approver and location.  It is also important to document any changes that take place within the company.  The change not only needs to be documented, but the reason for the change needs to be recorded as well. This documents should be created in such a manner that a new employee could read them and be able to perform any job in the company.  These documents are almost a step-by-step approach for the way that things are done within the company.

Flooring Compliances

In today’s market, there are without a doubt an overabundance of flooring materials available.  You can easily run down to the local hardware store and pick up some vinyl tile for an affordable price.  You could even spend a little more and get a more durable and satisfying hardwood.  With so many choices available it isn’t always easy to make the right choice for your new facility.  While the quality, cost, and functionality or each material are different you need to be aware of the fact that in order to meet GMP compliance, your facility is going to need a special type of flooring.  GMP regulations state that the flooring in your facility must have a smooth finish and be easily cleaned.

The FDA 21 CFR Part 211 Good Manufacturing Practice For Finished Pharmaceuticals, Subpart C—Buildings and Facilities states “Any building or buildings used in the manufacture, processing, packing or holding of a drug product shall be of suitable size, construction, and location to facilitate cleaning, maintenance, and proper operations.”

Stainless Steel Requirements

Stainless steel comes in a variety of grades and it is often used in the pharmaceutical industry.  There are compositions like 302, 304, 304L, 316, 316L, 410, 430, and 440. However, not all of these compositions are GMP compliant.  In fact, the only four that are compliant with GMP standards are 304, 304L, 316 and 316L.  316 and 316L are used when the equipment comes into direct contact with the pharmaceutical products.  This could include water system tanks and pipelines.  304-stainless steel is used for the non-contact equipment. 3 16 is much more resistant than 304 and allows more protection against acid and base attacks.

Personal Protection Equipment

Personal protection equipment is one of the best ways to avoid an injury in the workplace.  Not only does the GMP require employees to wear these items when they are exposed to risks, but they require employees to wear them correctly.  For instance, some PPE like hardhats or goggles can be uncomfortable, so employees don’t usually wear them on as tight as they should. This is why GMP requires that the employer train all employees on the proper way to use these items.  Keep in mind that PPE requirements can vary from case to case.

If you are a pharmaceutical company you might be required to wear goggles, over splash gloves, GMP approved scrubs plus you might have to have eye wash stations installed in areas where chemicals are handled.

Food Grade Food Containers Compliance

When it comes to the safety of food packaging this is a process that can be just as important as the safety of the food itself.  If food products aren’t stored in the right containers and packaging materials they can contaminate the food itself or expose it to hazardous environmental conditions.  The US FDA 21 CFR174.5 and EU Commission Regulation (EC) No 2023/2006 Act states that the proper food containers should be designed to prevent contamination in manufacturing, storage, and transportation of food products. It should also be noted that the regulations for this Act could vary from case to case due to the different types of foods and storage containers.

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