PHARMATEQ GMP SOLUTION reposted this
Qualification and Validation in Revised Schedule M 2024 for pharmaceutical manufacturers*: Good Manufacturing Practices (GMP) are all about making sure medicine is produced safely and consistently. Qualification and validation are like double-checking everything involved in this process. Imagine a factory that makes medicine. Qualification and validation are like making sure: The factory itself (premises), the utilities (like electricity and water), the machines (equipment), and the way things are done (processes) are all designed properly according to GMP rules (design qualification). The factory, utilities, and machines are built and installed exactly as planned (installation qualification). The factory, utilities, and machines work correctly when you use them (operational qualification). The entire process, from start to finish, can consistently produce medicine that meets all the quality standards (process validation). This way, we can be confident that everything works together smoothly to make high-quality medicine. Here are some other things to keep in mind: Anything that can affect the medicine, like changes to the factory or how things are done, needs to be checked through qualification and validation too. This isn't a one-time thing. Once everything is checked, there should be a plan to regularly review it to make sure it's still working correctly. Someone needs to be responsible for making sure qualification and validation are done properly. There should be clear instructions on how to do the qualification and validation checks. A report needs to be written to show the results of the checks. Based on the results, there might be a need to adjust how things are done. Some things need extra attention, like testing methods, automated systems, and cleaning procedures. By following these steps, pharmaceutical companies can ensure their medicines are consistently produced according to high-quality standards.