Research On The Construction Of Standardized Indicators For Daily Supervision Of Pharmaceutical Production In Beijing

Objective:Daily supervision and inspection for drug production is a way of administrative supervision on drug manufacturers with unrelated reasons and a certain frequency adopted by the drug regulatory authorities.It focuses on the actual conditions that drug manufacturers implement all the relative laws and regulations for drug production.Daily supervision and inspection for drug production is the requirement of our legal system and also a manifestation of the fulfillment of their duty for drug regulatory authorities.In the huge system of laws and regulations with the theme of GMP for drug production,drug regulatory authorities need to spend enough manpower and material resources in conducting daily supervision and inspection of drug production in accordance with the provisions of laws and regulations.However,the limited manpower and material resources for drug regulatory authorities make it hard to conduct a comprehensive daily supervision and inspection according to all the requirements of laws and regulations.So the drug regulatory authorities need to carry out some key inspections on drug manufacturers in the limited manpower and material resources conditions.Therefore,the present study is to filter out the key provisions from the system of laws and regulations with the theme of GMP for drug production,and then use them as indicators of daily supervision and inspection.Based on the filtered indicators,we can construct standard indicators system for drug production and endow different weight for every concrete indicator.These items will finally become standardized indicator and parameters for daily supervision and inspection in Beijing.Methods:The standard indicators system for drug production in daily supervision and inspection derive from three parts,including the indicators in drug GMP,the indicators in other laws and regulation and regulatory standards in daily supervision for some special drug manufacturers.Among them,screening indicators originating from GMP is to build the fault tree through fault tree analysis methods,then combine the basic events of fault tree with defective project in GMP certification inspectors.The content of daily supervision is concluded.The work choose<Regulations on Supervision and Administration of Pharmace-utical Production>and<Provisions for DrugRegistration>.Then select indicators from them to form the cotent of daily supervision and inspection of drug manufacturing.Implementa-tion of documents that the State Council and the City Council issue and implementation of special tasks are listed as the cotent of daily supervision and inspection of drug manufacturing.There are many types of special circumstances for drug production.However,just four types of special circumstances are listed in present work and serve as the standard indicators for daily supervision in drug production.These standard indicators can be adjusted according to the actual situation of drug manufacturers.This study endows the weight for the constructed indicators system using linear weighting method.Due to the weights are related to the expert scoring,the frequency of defects items,the theory analysis of Fault tree.So every index’ weight is calculated from expert scoring results,defective items frequency and fault tree theory analysis.Then through linear combination of the result of them,every indicator’s combined weight is calculated.Results:1 The constitution of standard indicator systems in daily supervision for drug production in Beijing:the established indicator systems consist of four parts,namely legitimacy,production and operation,change and risk control,special circumstance in drug production.The legitimacy is composed of three indicators,including legality of production conditions,legality of registration conditions and other regulatory compliance.The production and operation is composed of twenty-one indicators,including personal training,facility equipment maintenance,quality control for raw materials storage and transportation,supplier audit,quality management in storage and transportation for the final product,product shipments and recall,operation of the production staff,management for intermediate products,release for the finished products,equipment usage,environmental monitoring and cleaning,production process control,testing of raw materials and finished products,study on the stability in sampling and retention sample,the management for regent,reference substance,standard substance and culture media,verification and validation,management of computerized systems and product traceability,the integrity of production and packaging records,the integrity of inspection records,retrospective analysis of quality,self inspection.Change and risk control is composed of four indicators,including change situation,deviation management and corrective and preventative action and OOS inspection,risk assessment and control,unqualified project rectification in the last inspection.Special circumstance in drug production is composed of four indicators,including special drug administration,commissioned production,commissioned inspection pretreatment and extraction of traditional Chinese medicine in offsite and the sharing workshop inside the group.2 Weight assignment for indicator system.Through Microsoft Excel,every index’weight is calculated from expert scoring results,defective items frequency and fault tree theory analysis.Then through linear combination of the result of them,every indicator’s combined weight is calculated.Conclusion:1 Beijing Food and Drug Administration accepted the result of this study.Then they issued regulatory documents.2 In view of the constructed standardized indicators and parameters of drug production for daily supervision and inspection in Beijing,it is recommended that drug manufacturers should strictly enforce the constructed standardized indicators parameters and other laws and regulations,so as to ensure that the drugs meeting the intended use and registration requirements are produced continuously and steadily.3 Based on the constructed standardized indicators and parameters,it is recommended that drug regulatory authorities should strength the daily supervision on the quality of drugs,improve the pertinence and validity of daily supervision,effectively guarantee the quality and safety of drugs.