Influence Factor Analysis For Continuous Quality Verification

Drug is a special kind of product.It is related to people’s health and patient safety.A drug product needs to have four essential quality attributes,safety,efficacy,stability and homogeneity.In order to ensure that a drug product has these attributes,the Good Manufacturing Practice requirements need to be followed during the production,storage and transportation processes.And validation is a critical element of GMP and it is also an important component of the quality management system of a pharmaceutical enterprise for its healthy and robust operation.The documentation system for the life cycle process validation,the risk assessment approaches for critical quality attributes and critical process parameters,and the different impact factors for continuous process verification are established in this paper based on the advance concept of the life cycle process validation proposed by US and EU Drug Administration for the deficiencies in process validation in the pharmaceutical enterprises in China in combination with the practical experience of the author.In this paper the present situations of the process validation in the pharmaceutical enterprises in China are analyzed first and the common problems in process validation in these pharmaceutical enterprises are pointed out.Then the concept of continuous process verification is introduced based on the analysis of the life cycle process validation.And a comparison is made with the traditional process validation method while the specific execution procedures of continuous process verification are introduced.At the end,impact factors in continuous process verification are thoroughly analyzed for the four kinds of formulations,active pharmaceutical ingredients(API),oral solid doses(OSD),sterile products and biological products,by the author using the risk assessment method.The results show that designing and executing process validation protocols following scientific and innovative methods using the continuous process verification approach can have positive influences on the continuous improvements of the pharmaceutical quality system,especially in such areas as product release,change management,deviation management,product annual review and risk management.The successful use of risk assessment in the life cycle process validation is used to determine the critical quality attributes and the critical process parameters,and effectively identify,analyze and control the impact factors during continuous process verification,which provides assurances to the successful execution of process validation,the continuous control of the production process,the product quality and the ultimate patient safety.The author aims at providing some useful references and examples for eliminating or mitigating these impactor factors during the routine production activities of pharmaceutical enterprises through the analyses summarized in this paper.