Research On The Problems Of The Drug Quality System Management Of L Pharmaceutical Company

In year2010, China CFDA (China Food and Drug Administration) initiated the newversion GMP(Good Manufacturing Practice),which is updated base on the version1998,and also it is referred the USA/EU’s GMP. The new version GMP specifies the high levelrequirements&standard for production and quality management, and requires that chinalocal pharmaceutical companies should meet the version2010GMP requirements beforeend of year2015,if not, the pharmaceutical companies will be stopped production, andeven has the risk to be cancelled the GMP license. So far, many local pharmaceuticalcompanies cannot meet the version2010GMP requirements, hence, these companies needtake actions to solve the production and quality issues, and especially improve qualitymanagement system, to meet the new version GMP requirements.L Suzhou pharmaceutical company is the study objective of this dissertation, GoodManufacturing Practice and Global Quality System are the quality management baseline atL Suzhou phar. Company, but quality problems are existed in the quality managementsystem, include Deviation management, Complaint, Change management, and Validationetc. This study is to find the root cause of quality problems, include deviation issues,production issues, change control issue, and validation issues, and conclude that by rootcause analysis:1. Deviation improvement.2. Establish stable production management.3.Change control process improvement.4. Establish robust validation system.Quality management is a continual progress, L Suzhou phar. Company need toestablish a complete quality management system base on the GMP and GQS, and to reducethe quality safety risk, to drive the quality system into a high level. L Suzhou phar.Company objective is to strengthen drug quality brand, and also to achieve the integritypromise for patients.