Validated System Designfor Drug R&D Development And Registration

With the combination between informatization and industrialization,the word,Internet plus,is become a hot concept in nowadays' China.Informatization is hot not only used in management,but also in every corner of our daily life.And it plays a more and more important role.Informatization is used not only in information management,but also in every corner of our ordinary life such as shopping,payment and so on.Pharmaceutical industry is also needed informatization.Drug is a special product.Pharmaceutical industry is a special manufacture industry;all parts like design,sourcing,produce,warehouse,and transportation,sale need computerization to push the supply chain.But informatization level of pharmaceutical enterprises in China is low.It should be updated urgently.But it also must fulfill their special requirements such as GMP computerize system validation,total quality management,etc.After passing the audit of regulatory authority,the medicine can meet the requirement of quality assurance.But many factors like too many links,too long time,huge expense and lack of standardization,limitthe development of computerization.Due to pharmaceutical companies pay more attention on development & research,R&D has characteristics of huge system and high risks.If a product is transferred from R&D to commercialized production,it should be registered and examined by regulatory authority.R&D and registration are different but they also closely linked.R&D is the foundation of registration.Registration is the purpose of R&D.The different persons for two majors will impact the progress of new drug marketing.This article has described the current situation of management drug product's development & research and application for registration.It introduces the structure and requirement of ICH registration.A informatization management system was designed to improve the efficiency of R&D and registration.This will solve some problems like long cycle and huge documents in the current flow of drug product's development & research and application for registration.This article involves many aspects of knowledge including drug registration,project management,the computerization system validation,coding and database.This article has provided helpful advice to Chinese pharmaceutical enterprises in informatization development.