In general, radioactive substances are thought of as bad for our health. In some cases, radioactivity can lead to severe health effects. While this is true in excess, there are many instances in which radioactivity can benefit our health. In the medical field, radioisotopes are valuable assets to diagnostic and therapeutic needs. Let’s take a more in-depth look at the uses of radioisotopes in medicine.Read more
Clinical trials are essential to medical research. Bringing a new drug to the market largely relies on safe and effective clinical trial results. However, finding willing participants to participate in clinical trials can be challenging. Many patients may find the idea of trying a new drug too risky even to consider taking a substance that is still in the clinical trial phase. Without a large pool of patients willing to take this risk, your drug won’t ever see the market, or you risk receiving varying results. Use these tips for recruiting clinical trial participants to run the best clinical trial possible.Read more
Modifying nucleic acids with tags allows for the detection and purification of the nucleic acid (DNA or RNA) during synthesis. The resulting nucleic acid probes identify or recover other interacting molecules as well. Radiolabeled compound suppliers use enzyme and chemical methods to label the nucleic acid at the 5’ or 3’ ends of the oligonucleotide, as well as randomly throughout the sequence. Here are a few of the most common methods for labeling nucleic acids.Read more
For a drug to be clinically effective, it must absorb into the bloodstream. Absorption is the process of a drug moving from the site of delivery to the bloodstream. The absorption process is crucial to treatment, but it is complex and can be challenging to understand. Here’s what you should know about drug absorption.Read more
Quality control is one of the most critical aspects of manufacturing and selling products. That’s why it’s crucial to use a GMP certified manufacturing company to manufacture goods, especially pharmaceuticals. But what does it mean to be a GMP certified manufacturer? Let’s take a look.
What Is GMP
GMP stands for good manufacturing practice, and it is a system that ensures products consistently adhere to quality standards. GMP regulations were put in place by the Food and Drug Administration (FDA) to minimize the risks involved in producing goods, such as supplements and other pharmaceuticals.
GMP covers all aspects of production, from the materials, manufacturing location, and equipment to the training, PPE, and staff’s personal hygiene. According to GMP guidelines, detailed written procedures are essential for each process that could affect the finished product’s quality. Every step of the manufacturing process must come with documented proof of the methods used to show that every product is made with consistency.
Why Being GMP Certified Matters
Being a certified GMP manufacturer is of the utmost importance. It is nearly impossible for a consumer to determine if a drug is safe or effective by simply looking at the pill. This is why GMPs are necessary, as they protect consumers from potentially harmful medicines and supplements.
GMP certification not only gives manufacturers a strong reputation as a trustworthy and responsible facility, but it also shows that they produce their products at the highest level of quality possible. When a manufacturer has a GMP certification, they can guarantee that a product was made in an FDA approved facility. Furthermore, this means the manufacturer is taking all the necessary quality control steps to produce safe and effective products.
Pharmaceutical manufacturers and businesses that are looking to outsource their manufacturing needs should never overlook what it means to be a certified GMP manufacturer. At Moravek, we take quality culture seriously; that’s why we’re a trusted GMP certified API pharmaceutical manufacturer.
Every new product that hits the market, including new pharmaceuticals, must follow regulatory compliance. Regulatory authorities issue guidelines and rules for development, licensing, manufacturing, marketing, labeling, and more. While strict guidelines may seem like a pain, they are highly crucial to pharmaceuticals’ safety and efficacy and their development process. Improved standard methods, efficiency, and costs are a few of the values of growing for regulatory.Read more
There is a lot of information that goes into understanding DNA and RNA radiolabeling. Radioisotope labeling is a traditional method for nucleic acid labeling, and it is highly essential to the detection, visualization, and purification of DNA and RNA.Read more
An impurity in pharmaceuticals is classified as any component that is not the entity defined as the drug substance. In addition, for a drug product, any component that is not a formulation ingredient is considered an impurity. There are three different types of impurities in pharmaceuticals that API manufacturing companies must be wary of. Below, we provide a more in-depth look at each of these three types of impurities.Read more
Metabolism is the biotransformation that some drugs undergo when the body chemically alters them. Metabolism is an important process that produces the intended therapeutic effects of a certain drug and eliminates the drug from the body through urine or bile. Drug metabolism can be tricky to understand—here’s everything you need to know about how drugs are metabolized in the body.Read more
Good manufacturing practice or GMP is a system that ensures products are consistently produced and controlled according to quality standards. The importance of GMP in pharmaceutical manufacturing is to minimize the risks involved in any pharmaceutical process, such as custom radiolabeling, that can put consumers at risk if the proper quality control isn’t in place.Read more