The production and distribution of pharmaceuticals are heavily monitored by the Food and Drug Administration in order to ensure the highest quality of drug for consumers. Current Good Manufacturing Practice regulations – or CGMPs for short – are enforced by the FDA in order to verify that every drug being researched and manufactured is safe. These CGMPs are what facilitate the faith placed in the effectiveness and safety of pharmaceuticals which is why following these regulations when using your industrial stirrers is so important.
There are many steps to the production of pharmaceuticals and each one is equally as important as the rest. Factors such as poor hygiene, temperature control, and cross-contamination can influence drug production and the result may pose negative health risks to consumers and the environment alike. The FDA relies on regular inspections of manufacturing facilities as well as reports of potentially defective drug products from the public and industry to ensure that every drug manufacturer is compliant with all regulations. Additionally, CGMPs are the “bare minimum” requirements and many pharmaceutical manufacturers implement their own quality systems that are even more thorough and advanced.
There are multiple basic CGMP guidelines in place to assist manufacturers with ensuring that their processes using industrial stirrers are as streamlined and efficient as possible, including quality management, sanitation and hygiene, equipment, validation and qualification, and inspections.
- The principle of quality management involves the implementation of several checks, such as quality control and quality risk management, to make sure that all manufactured products are fit for use and do not place consumers at any risk.
- Sanitation and hygiene guidelines are in place to prevent any contamination of drugs during their manufacturing process, which can be caused by the personnel working on the drug, the equipment and containers used to store the drug, or the production materials used to create the drug.
- All equipment, such as your key laboratory stirrers that are used in the manufacturing of drugs should be located and maintained according to its instructions in order to maintain proper function. This includes using the proper equipment for your job, as well as storing it and cleaning it correctly. All defective equipment must be disposed of to prevent manufacturing defects.
- In order to optimize the work done by your equipment, systems, and premises, CGMP guidelines mandate that you verify all your equipment, from magnetic stirring systems to cuvette stirrers, to be following its intended use and able to consistently produce high-quality products. Validation and qualification involve providing documentation that all your utilities and equipment have been designed in accordance with the requirements for CGMP, and also that they have been installed and operate in compliance with their design specifications.
- Finally, a system of regular inspections must be implemented in order to monitor the CGMP compliance of all your stirring systems. If any areas require optimization, make note of it and take the corrective measures.
When it comes to CGMP compliance within your organization, it is usually best to keep it simple by utilizing easy-to-use systems, using current equipment, and implementing processes to check the efficiency of your premises. Reliable equipment is key in consistently manufacturing at a high level, and we offer a selection of the best industrial stirrers, stirring hotplates, and more for these needs. Contact 2mag today to learn more about our magnetic stirring systems and how our magnetic stirrers, such as our submersible stirrers and stirring bars, are the best equipment to ensure for CGMP compliance and the most efficient production.