Accurate and precise measurements are vital in the pharmaceutical, medical device, and other FDA regulated industries....
The environmental monitoring program in sterile drug manufacturing
Many controls are well-designed and put in place to help drive and maintain the quality of the sterile drugs produced by aseptic processing. Perhaps one of the most important controls is the environmental monitoring (EM) program. The main purpose of the program is to document the state of control of the facility and aseptic process; however, it does not determine the quality of the finished drug product.
EU MDR: Extending the Transition Period for Medical Devices
The European Commission has implemented a proposal to extend the transitional period to certify medical devices under the Medical Devices Regulation (MDR). The proposal allows more time for manufacturers to transition from the previously applicable rules to the new requirements of the Regulation