Understanding GMP Storage Condition Standards

Currently, the United States is responsible for 45% of the pharmaceutical market worldwide. With respect to this, GMP storage conditions are especially important in this industry. At a glance, GMP is a system that works to ensure that products are consistent and controlled with respect to quality standards. In the pharmaceutical industry, this helps minimize the risk of contamination and potentially dangerous mixups with products.

Read more

Radiolabeled Compound Handling 101

The United States remains to be the leading producer of various chemicals associated with drugs, food additives, and preservatives. With this title come several challenges, such as accidents happening in various laboratories and chemical manufacturing plants. As a leader of a chemical producing plant, you already know the accidents associated with such chemicals, especially radiolabeled compounds.

Read more

Good Manufacturing Practice — What Do These Guidelines Dictate?

gmp quality control

When you are creating pure, high quality radiolabeled compounds, you need to hold your production process to the absolute highest material and clean room standards possible. There is a reason Moravek was given two large grants by the National Institutes of Health — it is due to strict adherence to Good Manufacturing Practice, or GMP.

Read more

Understanding Carbon-14 Use In Pharmaceutical Manufacturing

radiolabeled compounds

In the United States, an estimated 810,000 people work in chemical production fields, including the pharmaceutical sector. In this industry, C14 radiolabeling remains the standard and is the first choice for the labeling of active pharmaceutical ingredients. This type of labeling is crucial for API GMPs, as it permits more information to be collected pertaining to metabolism, distribution, adsorption, and excretion — all of which can be critical to understanding the pharmaceutical during the clinical study stages.

It’s important to note that, in recent years, APIs (along with their delivery methods) have increased in complexity as research has progressed and unearthed new discoveries. This means that radiolabeling now contains new challenges, which has prompted new technologies to be employed to ensure process efficiency.

Read more

Fume Hoods: Proper Usage and Maintenance Tips

fume hoods

Fume hoods are an important part of any laboratory. Aiding in ventilation, these exhaust systems help remove harmful chemical fumes from the air (for instance, during radiolabeling or GMP synthesis) to better ensure the safety of scientists and personnel. Fume hoods are a crucial part of maintaining clean room standards and can prevent an excess amount of vapor, aerosol, gases, and dust from accumulating in the air.

Read more

6 Safety Tips for the Handling and Storage of Radiolabeled Compounds

radiolabeled compounds

The U.S. is the leading national producer of chemical products around the world. The vast majority of laboratories in the country use most of these chemicals. The types and amounts of chemicals used vary from lab to lab based on whether the lab focuses on compound production, research, basic acid digestion, and so on.

Read more

From Blush to Allergy Medications: Industries That Require Chemical Purity

Chemical purity is no joke. It requires extensive testing and all conditions must be met in order for a proper purity grade to be earned.

Chemical purity is best defined as an untouched and unmixed substance. A chemical or product must achieve this before it is sold on the shelves of drugstores across the nation. This rating deems that the medication or product is safe for human use.

While many industries require chemical purity, there are some that the average consumer might be more familiar with. Here is a quick look into the main chemical manufacturers that utilize this idea to deliver safe and effective products.

Read more

The Importance of Maintaining Clean Room Standards

Whether you are concerned with chemical purity, the efficiency of your fume hoods, or ICN radiochemicals, you cannot overlook the critical importance of maintaining clean room standards. Even if you acknowledge the importance of keeping up to date, it can still present a set of unique problems and complications that necessitate constant monitoring and ongoing education. Follow our simple guide if you want to be sure that you are operating in accordance with clean room standards.

Read more

Understand GMP Quality Standards And How They Affect Labs

fume hoods

Laboratories are home to a number of different chemical compounds. Many don’t think about what goes on within labs — despite the fact that, physically, they take up a lot of space in the United States. Right now, nearly half of the global pharmaceutical market is taken up by the U.S., and the U.S. is among the world’s largest producers of chemical products on a global level. For that matter, chemical products are not limited to pharmaceutical products. A number of other products are created and tested within labs. With that being said, it can be difficult for labs to maintain the level of safety standards that they should — yet they must. Thanks to GMP standards and resources today, laboratories have standards to follow. Not only will these standards and guidelines ensure that those that work within laboratories are safe — but those that use chemical products as well. Below, we’re going to look into these practices, as well as the specific steps that laboratories can take to ensure that they’re producing products of the highest quality, at the safest standards possible.

Read more