The Process Validation (PV) Guidance from the FDA (January 2011) adopts the product lifecycle concept, emphasizing the expectation that process validation starts with process design and carries.
Equipment qualification is critical in the pharmaceutical industry. The equipment not only includes manufacturing equipment but testing and sampling equipment also to name a few. Even the slightest.
So, your new product is ready for the next step – commercial manufacturing production. You have decided not to invest in new equipment or building a new manufacturing line. You’re now looking to.
After 1990, the pharmaceutical industry shifted due to increased R&D spending, changes in the health insurance system, and the competition from new drugs and ones that were going generic. This shift.
Bora Pharmaceuticals has come up with a way to benefit our Zhunan site by converting the waste heat generated from our steam system. To support operations running smoothly at the Bora Zhunan site,.
We here at Bora are often asked by our clients what the best approach to maintaining tablet compression tooling to maximize the life of the tooling and optimize performance during production so that.
Synchronizing and controlling API delivery, extrusion-spheronization is a robust technique offers pharmaceutical companies a reliable, efficient way to modify and control the release of many of.
