The life science industry cannot do without Good Practice standards. You’re going to find a lot of GxPs regarding each process along the way. Drug development is no different, being an integral part of the life science manufacturing industry. Something else must be kept in mind- it’s not just the manufacturing process that is regulated by these GxP standards. From the initial testing to the final packaging and distribution, every process is governed by some or the other Good Practice standard.

Since there are multiple GxP standards, a common problem often arises. People often get confused between GLP GMP procedures. It’s even more puzzling because both of these standards are required in the drug development industry. However, the chief difference between them is that they are needed in different stages of drug production.

So, why is it so important not to use GLP GMP procedures interchangeably?

It’s because your product can get pulled from the market for not following GMP standards before packaging and distribution. In worse cases, drug manufacturers who are negligent in following GMP standards religiously are even sued and receive jail time.

What are these GLP GMP procedures concerned with?

Broadly speaking, any of these GxP practices are concerned with quality assurance or quality control. However, there are many nuanced differences between them which are going to be explored thoroughly in this article.

There are two key points you need to understand to differentiate between GLP GMP procedures:

  1. When is each applicable?
  2. How to implement/practice each?

Let’s get started by comparing the two standards with one another.

GLP vs GMP Procedures

The first thing you need to remember about both of these procedures or standards is that they are very industry-specific. Food manufacturing companies have to follow separate GMP procedures from drug development companies. This article will focus on GLP GMP procedures for the drug development industry specifically.

Why do we need to follow these procedures?

The answer is simple- To get replicable results. Whenever we carry out experiments in the lab, certain standards or basic rules need to be followed. Otherwise, the control situation itself changes, and the results which are obtained after each round of testing turn out to be different. In drug development, not only do you need to produce several badges of drugs with the same chemical composition, but you also need to ensure that this chemical composition is maintained in all future batches for generations to come until the formula is changed. There is no way you can maintain this level of uniformity in results unless you follow a set of standard rules.

The same is valid for the manufacturing, packing, and distribution process. If any of these conditions change, the product itself will change. To ensure that the same product is being piped out into the market consistently, you need to ensure that the packers and distributors are following a set of basic rules as well.

However, this is where the similarities between GLP and GMP end. Now, let’s get to the differences.

The gist is this: GLP standards focus on the study and research carried out at the lab while GMP standards focus on the final production process. Now, let’s delve into the details.

GLP or Good Laboratory Practices

As previously stated, GLP standards mostly focus on the conditions and processes of the laboratory testing setup. They are basic rules regarding the documentation and archiving of the tests. It’s not enough to experiment. Each of its processes has to be documented, and the result has to be archived so that future experimenters can review them.

Long story short, the experiments need to be preserved as trackable data so that the product has real validation in the market. And as already mentioned, without trackable data and detailed archives, there is no possibility of producing replicable results with the same formula in the next few decades.

Though there is a common misconception that FDA only established GMP standards and not GLP, it was set up by the FDA in the 1970s. Another common misconception is that GLP is concerned with clinical studies as well. This is not true. GCP or Good Clinical Study Procedures are followed in the case of clinical studies.

It is not enough to have trackable data. The integrity of this trackable data has to be preserved over time, and this is exactly what GLP helps with.

GMP or Good Manufacturing Practices

GMP procedures, unlike GLP, are concerned with the manufacturing processes solely. Therefore, companies have to abide by not just general rules set by the FDA but also the rules of the local regulatory body. This is because the drug companies are ultimately selling their goods in a market under their jurisdiction. Therefore, they have to be responsible towards the local community, consuming these drugs.

GMP standards can change with time. Therefore, you might come across the term “cGMP”, which means current GMP. These guidelines tell you how the lighting, hygiene, plumbing, and storage of the manufacturing facility are supposed to be. Not just this, they also provide maintenance guidelines for the equipment which are involved in these processes. Another very important point that GMP stresses are the separation of manufactured substances so that there is no possibility of contamination.

Interestingly, but perhaps not surprisingly, GMP came around half a century before GLP procedures were established by the FDA. The FDA came up with these standards in 1938 for the quality assurance of the manufacturing process of packaged foods, cosmetics, and drugs. GMP, like GLP, also ensures that the end products of the manufacturing process can live up to the pre-approved requirements and are also replicable.

In Conclusion

GLP procedures are followed during the initial testing, while GMP procedures are followed during the manufacturing process. On a very fundamental level, both of these procedures diminish, if not completely remove, the possibility of human error that mostly stems from subjective judgment calls. Also, there is a reduced possibility of the quality being diminished due to the lack of human expertise. Something that you need to remember is that the data that is archived following both GLP and GMP procedures need to be stored for a significant amount of time. Local and federal regulatory bodies might review these records in case any problem arises with the drug later.