Why Radiolabeling Services Need to Adhere to GMP Standards

Maintaining GMP standards in laboratories is important not just for ensuring staff safety, but for ensuring contamination doesn’t spread to consumer products. A fungal meningitis outbreak was traced to a pharmacy where protocols and sanitation were being overlooked. By the time the drug was recalled 48 people had already died from the contaminated drug. GMP standards exist to prevent incidents like this from happening, and even in labs that focus primarily on custom radiolabeling, the same procedures apply. If you’re looking for radiolabeling services, ensuring you find a company that adheres to high GMP standards is key.

Selecting the Best Laboratory

Before sending samples for radiolabeling, it’s important to speak with the company and see what services they can provide. A couple of the most significant points to ask on include:

  • Does their methods of radiolabeling work with the samples you’ll be sending?
  • Are their clean rooms in line with GMP standards?
  • Will they provide updates during the process?
  • Will they confirm shipping and storage conditions to prevent contamination or degradation of the sample?
  • Can they provide clear documentation of the process performed?

These are just a few of the most important things to ensure before trusting a laboratory with custom radiolabeling.

There are many radiolabeling services around the county, but not all of them are able to deliver the standards needed. You want a service that is able to maintain high GMP standards, especially if samples will be used during human trials. Communicate your needs and don’t hesitate to ask questions before deciding on the lab that will best suit your needs. This way, you won’t have to worry about losing valuable samples due to poor standards or inappropriate lab conditions.