One of the biggest concerns for pharmaceutical companies is the presence of impurities in a drug or medication. Contaminants do not offer any medical benefits and can be detrimental to the intended therapeutic effects of the pharmaceutical. Though it is difficult to avoid all impurities, here are a few tips for how to reduce pharmaceutical impurities when possible.
Using the Right Supplier
Doing ample research before you decide to outsource your medication manufacturing is a critical step in reducing impurities. If you’re using a less experienced supplier or your supplier isn’t GMP certified, you may be increasing your likelihood of finding contaminants in your product batches. GMP certification shows that the supplier you’re working with follows all the proper protocols and protections to produce safe, impurity-free products.
Material and Process Controls
If you aren’t outsourcing your product, pay special attention to the materials and processes in your lab. The materials and methods you use when creating a drug will significantly impact the drug’s purity. Outside contaminants can easily come in contact with a drug during its creation. Putting controls in place to limit contamination, such as using proper PPE and designated workstations, can help determine the risk of impurities.
Detection and Quantification Practices
The detection and quantification of impurities are vital processes to include in your production. Running tests with practices such as high-performance liquid chromatography can identify each impurity present in a batch. This process can also quantify how much of each impurity is present. Since some contaminants are not a threat to humans, you can compare the test results to FDA guidelines to determine if the product is safe.
Avoiding impurities is an important practice for producing high-quality, safe pharmaceuticals. While some impurities aren’t detrimental to drug safety and efficacy, others can have drastic adverse effects. Follow these tips for how to reduce pharmaceutical impurities in your products.