Книга: Mitesh Patel,Kanu Patel and Mukesh Patel «Process Validation, Area and Equipment Qualification»
|
Производитель: "LAP Lambert Academic Publishing" Manufacturing area with new equipment having high capacity compared to previous one (Production Line) i. e. FBD, RMG, Co Mill and Container Mixer. Manufacturing of Metformin ER 500mg tablets is planned to do in new area with new equipment. As the size and capacity of the equipments are bigger than previous equipments, batch size of Metformin ER tablets is increasing from 0. 4 mio to 0. 6 mio. As the production in new area and new equipment, qualification of area, equipment, water and air was carried out as per qualification protocol. Now, further the process of optimization was performed for Metformin ER tablets by identifying the critical Process parameters i. e. standardization batch (BATCH I). Before going to start process validation, one standardization batch was taken, where the process optimization of critical parameter like mixing speed, mixing time, lubrication time was carried out; fast, 15 min, 15 min respectively the results for that. Three process validation batches (PV-1,... ISBN:9783659405082 Издательство: "LAP Lambert Academic Publishing" (2013)
ISBN: 9783659405082 |
См. также в других словарях:
Verification and validation — IV V redirects here. For NASA s IV V Facility, see Independent Verification and Validation Facility. Verification and validation is the process of checking that a product, service, or system meets specifications and that it fulfills its intended… … Wikipedia
Land and Property Laws in Israel — refers to the legal framework governing land and property issues in Israel. Following its establishment, Israel designed a system of law that legitimized both a continuation and a consolidation of the nationalisation of land and property, a… … Wikipedia
Israeli land and property laws — Land and property laws in Israel provide a legal framework which governs land and property issues in Israel. At its establishment, Israel continued to apply the pre existing Ottoman and British land law. Over time, these laws were amended or… … Wikipedia
United States Military Academy — West Point and USMA redirect here. For other uses, see West Point (disambiguation) and USMA (disambiguation). United States Military Academy at West Point Motto Duty • Honor • Country … Wikipedia
Information Technology Infrastructure Library — The Information Technology Infrastructure Library (I), is a set of good practices for IT service management (ITSM) that focuses on aligning IT services with the needs of business. In its current form (known as ITILv3 and ITIL 2011 edition), ITIL… … Wikipedia
Specification (technical standard) — Specification redirects here. For other uses, see Specification (disambiguation). A specification (often abbreviated as spec) is an explicit set of requirements to be satisfied by a material, product, or service.[1] Should a material, product or… … Wikipedia
