It’s generally nerve-wracking when the US Food and Drug Administration (FDA) shows up at your door for an inspection. Even if you’re confident that everything is in good shape around every corner. To ensure compliance with regulations, the FDA conducts inspections of all registered establishments. Once the inspection is closed out, it is categorized in […]
Requested By: for KVR SudhirOrganization: PharmaceuticalsCategory : Parenterals Questions A. VIAL WASHING MACHINE QUESTIONS 1. What is purpose of vial washing machine? Objective: Cleaning of Vial externally and internally to reduce the bio-burden. Note: It is used as a primary packing material. 2. Why compressed air and recirculated water used for washing? Compressed air used […]
The control and monitoring systems are considered the core of the environmental control system. The final performance of the environmental control system can be evaluated only after these have been validated. PQ protocols covering this system, in general, include the performance challenges for the all the components of the environmental control system described in the […]
