V-Model Based Validation Management Improvement Study Of Manufacturing Equipments In B Plant

Manufacturing equipments validation management is a part of pharmacy company validation system. Also it's a key control point of performing products quality management and the initial requirement comes from GMP. GMP is the short term of good manufacturing practice which is the basic following quality management system of pharmacy industry. The GMP validation is a key components of GMP system, means a group of action to verify the any program, manufacturing process, equipments, material, operation and system can contribute the original defined results.As a member of pharmacy industry, with the growing trend of China medical care reformation, B plant made a series of capacity expansion project in the last several years. And the next facing problems are these new adding and modified equipments'validation management jobs. These jobs are not only caring in validation period but in the whole life cycle of equipments launch include: quality risk assessment, user requirement specification, system specification, technical design development and the following detail validation performing things as design qualification, installation qualification, operational qualification, performance qualification etc, and also about the change control's requirement. This whole validation life cycle, is a continuously process, we can't deal with them one by one. In the quickly expansion climate, how to perform the validation management of manufacturing equipments on right point and make sure the stable of products is the key subject of different management level.This study is to make the description and analysis with the current status of B plant's manufacturing equipments validation management. Let all related person will enhance the knowledge of products and processes, then using the suppliers knowledge, experience and documentations, to finish the smoothly launch the equipments, reduce the production cost& increase quality level. Also base on the V-model management skill to clarify the validation management job should be the under project management structure before-launched equipments life cycle management...