It is important that manufacturers of isotopes and radiopharmaceuticals maintain consistent high quality when supplying pharmacies and PET centers. It is critical that the products provided by the nuclear medicine industry allow for safe and effective imaging and treatment of disease. Toward this end, good manufacturing practices have long been promoted by the FDA to maintain the highest level of quality. What are some of these GMPs?
Managing inventory is a major concern for every good manufacturer. With nuclear medicine manufacturers, it is especially important to handle nuclear isotopes according to strict procedures. Raw materials must be received into the facility under specific acceptance criteria. It is also a requirement to track any nuclear waste generated by the production process. Many manufacturers are finding that advanced bar coding software systems that can automatically label and track radiopharmaceutical products throughout the facility are providing a significant business advantage.
With nuclear medicine, there is always a plethora of documents. Keeping track of paper documents can be time consuming and cumbersome. Good manufacturing practices are enhanced by using a software system that is designed specifically for nuclear medicine, with an electronic document repository that provides for document change control, and production records and reports that are easy to call up in the event of of FDA inspections.
With every manufacturer, employee training is important. With nuclear medicine, it is mandatory. Keeping your employees well trained will keep your facility producing quality products, but training records and certifications can add up to even more paperwork . If a customer inquires about your employees’ qualifications, having a software program that can not only schedule and deliver training, but also print the training records will help enhance customer service and build trust.
Maintaining facility equipment is essential for a manufacturing facility. If production equipment should malfunction, orders may not be able to be filled in a timely manner, or quality issues could result. When it comes to nuclear medicine, that could mean someone is not getting his or her radiation therapy drugs. Automatic scheduling of equipment maintenance and certification, along with easily retrievable records, can make the difference for the equipment management efforts of radiopharmaceutical manufacturers.