Research On The Quality Risk Management In Production Of Oral Solid Dosage Form Of Drug

Drug oral solid dosage clinical is widely used, and the quality has been considered to be stable,therefore people do not pay to it as much as injection.But the safety of oral solid dosage forms can not beignored. The2011version GMP put forward the concept of quality risk management and demanded that allthe pharmaceutical manufacturing should pass the medicine GMP standard by the end of the year2015. Inthe medicine producing enterprises how to carry out the quality risk management becomes the focus ofpublic attention. In this study, the drug oral solid preparation is the main content and analyze systematicallyof the drug quality risk management practice, research status and development; Analyze of the oral soliddosage formulation and its implementation the approach of production of quality risk management, and tryto use risk management tools to establish risk management models, designed to provide a reference for theeffective implementation of pharmaceutical oral solid dosage production of quality risk management.In this study, I use content analysis, survey research and empirical research methods and try to use adifferent quality of risk management tools. Content analysis focuses on the basic theories and methods ofrisk management and its application in pharmaceutical production and quality management, the oral soliddosage formulation characteristics and its implementing ways of production quality risk managementsystem study involving literature including the2002to2012annual domestic risk management,pharmaceutical risk management related documents, regulations, papers, designed with and so on; surveyresearch for clinical application case of oral solid preparations, from2010to2012SFDA qualitycommuniqués and ADR announcement reflecting the oral solid preparations quality security situationsystematic analysis of data, and analyze Luoyang City, New Year bio-pharmaceutical Co., Ltd. oral soliddosage forms production status; empirical research focused on oral solid dosage production and Radixlozenges and Pediatric Paracetamol Atificial Cow-bazaar and Chlorphenamine Maleate Granules,try to use different tool for the implementation of production quality risk management. Building oral soliddosage’s production of quality risk management model by RRF, building Radix lozenges’s production ofquality risk management by FMEA, building Pediatric Paracetamol Atificial Cow-bazaar andChlorphenamine Maleate Granule’s production of quality risk management by HACCP.The results show that there is a big advantage in the drug oral solid dosage formulations, production and clinical applications. In the essential drug list accounting for62.9%, in the domestic chemical medicineaccounting for51.1%, in the domestic Chinese medicine accounting for76.8%, in the OTC chemicalsaccounting for62.8%, in the OTC varieties of Chinese medicine accounting for69.6%, in the health drugsaccounting for67.7%. There is a big potential risks in pharmaceutical oral solid dosage, there is56.6%oralsolid dosage forms in the SFDA sample the substandard drugs in2010-2012; There are37.0%and39.3%oral solid dosage forms in National Adverse Drug Reaction Monitoring Center received in2010and2011.In Henan Province, Center for Drug Evaluation ADR reports received oral solid dosage up to63.8%and64.1%. It is mainly concentrated more in the injection, blood products, and high-risk species of quality riskmanagement for production than oral solid dosage. The literature about oral solid dosage risk managementis only42.9%of injection.The results shows that using RRF to analyze statutorily of oral solid dosage production process riskand hierarchy and identify high-risk procedure and the implementation of appropriate control measures, therisks can be controlled at an acceptable level; In the production of Radix lozenges,using FMEA to analyzemain failure and the reasons for existing in the process, form, probability, calculated risk priority indexRPN, arranged the risk priority and control measures can effectively reduce the level of risk; In theproduction of Pediatric Paracetamol Atificial Cow-bazaar and Chlorphenamine Maleate Granule’s,using HACCP to analyze particles products, processes hazard analysis critical control points, criticalcontrol points to accept the risk of the standards, establish the key monitoring system and control measures,the risk can be eliminated or reduced to a safe level.The results show that implement the production quality risk management of pharmaceutical oral soliddosage forms can be ensure production quality to and is the GMP’s requirement, is the problems to besolved in the pharmaceutical production and quality management activities. Building a scientific, effective,convenient and applicable model of production of quality risk management can ensure the effectiveimplementation of risk management protection of pharmaceutical oral solid dosage production quality. Wecan use different ways to construct drug oral solid dosage production quality risk management modelaccording to its characteristics. The theory, processes and methods provided by ICH can support for theconstruction of quality risk management models of oral solid dosage risk management.The innovation of this research lies in using the method of risk management for the first time to assess and control the production of oral solid medicine and specific drugs and establish the production qualityrisk management system.