Quality Assurance And Quality Control
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Added on 2020-10-23
Quality Assurance And Quality Control
Added on 2020-10-23
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Quality Assurance andquality control
Table of ContentsTable of ContentsModule 7..........................................................................................................................................31 New philosophy companies.................................................................................................32 Quality assurance depends on two focal points...................................................................33 The Japanese integrated quality throughout their organization and developed culture of..34 Not included in the form of improvement encouraged under total quality ?......................35 The specific concern of total quality management..............................................................31 Total quality management...................................................................................................32 Objective of total quality management................................................................................33 Benefits of quality system.................................................................................................44 Steps of PDCA....................................................................................................................45 Hazard analysis and critical control points.....................................................................46 ICH objectives....................................................................................................................57 FMEA and its area of use ?..............................................................................................58 Quality risk management for facilities and equipments......................................................59 Explanation about the corrective action and prevention action..........................................510 The activities that should be conducted to mange and continuously improve thepharmaceutical quality system...............................................................................................611 The objective of FDA guidance on quality system approach to pharmaceutical GMPregulation................................................................................................................................612 Quality system models......................................................................................................613 How are nonconformities and deviation handled in any quality system...........................614 Explain the ISO standard related to risk management......................................................715 Describe in brief REMS....................................................................................................71 Quality management detail..................................................................................................82 Primary elements of Total quality management..................................................................83 General quality risk management process as per ICH guidelines.......................................94 GMPs and the concepts of modern quality systems............................................................95 Management responsibilities in quality system models......................................................9
Module 8........................................................................................................................................101 Ideal frequency of conducting...........................................................................................102 Tablets and capsules are susceptible to airborne contamination due to the......................103 A sterile drug product is....................................................................................................104 When the organoleptic examination does not conclusive evidence the inspector shall havesample tested using which method ?....................................................................................105 L.A.L stands for:................................................................................................................101 Define inspection and its objectives..................................................................................102 Objective of performing re inspection...............................................................................103 Describe the roles and responsibility of the inspector.......................................................114 What is the site master file ?..............................................................................................115 Four classification of drugs and significance of national drug law...................................116 Essential for pharmaceutical inspectorates to establish and maintain liaison with OMCL117 Method of sterilization process?........................................................................................128 What specific information should be evaluated for the cGMP compliance of intement,liquids and lotions as per US GMP regulations....................................................................129 What are role does supervisory authority in Europe.........................................................1310 Objective of site inspection as per UK MHRA...............................................................1311 Critical deficiency and major deficiency under UK MHRA...........................................1412 I.A.G................................................................................................................................1413 Language of the quality system audit reports according to health Canada ?..................1514 Role of the GMP inspectorates per Medicines control council of South Africa.............1515 The principles of self-inspection as per medicines control council of south Africa.......15a) Types of audits.................................................................................................................15b) The qualification of the drug inspectors...........................................................................16c) Organizational aspect of the drug inspectors...................................................................17d) Current good manufacturing regulation as per US FDA.................................................17e) Determination for the laboratory controls in order to conform with appropriate standard18Module 9........................................................................................................................................181 Set of authorize written procedure....................................................................................182 Which of the following is not a type of Drug master file as per US FDA.......................19
3 The batch production and laboratory control record should be reviewed and approved by194) Which of the Sub part of 21 CFR parts 211 contain record and reports ?.......................195) In which level company policies are ordered in Hierarchical document system ?..........191 Need of documentation in pharmaceutical industry..........................................................192 WHO good distribution practices for pharmaceutical products........................................193 The difference between standard operating procedure and protocol?...............................204 Describes the control of Document as per ISO 9001-2003...............................................205 Describes the record for storage condition and stock control...........................................206 Description about Drug master file and site master file....................................................207 Record for raw material and intermediates.......................................................................218 What is the complaints record and discuss the information to be included in these records219 Describes the specification for starting material, intermediate product, packaging materialand finished products as per PICS........................................................................................2110 Format of SOP and list out the information to be mentioned in SOP.............................2111 Batch manufacturing record view...................................................................................2212 Common technical document and describes the different module of CTD....................2213 Documentation of extemporaneously prepared product..................................................2314 Describe the record for recall and returned product........................................................2315 The electronic manufacturing and batch records.............................................................231 Laboratory control record and WHO guideline for preparing laboratory information file242 Detail note on US FDA guideline on drug master file......................................................243 Master production and control records..............................................................................244 Complaints file and laboratory records as per records and reports sub parts of 21 CFR..245 Batch production and manufacturing and batch packaging record in detail.....................25
Module 7Section A1 New philosophy companiesA Customer driven approach2 Quality assurance depends on two focal pointsC time and motion guideline and management policy on quality3 The Japanese integrated quality throughout their organization and developed culture of A continuous improvement4 Not included in the form of improvement encouraged under total quality ?A Reducing waste5 The specific concern of total quality managementA Primarily a worker rather than a management activitySection B 1 Total quality managementTotal quality management is way to deal with make business subjective and successful.As indicated by this idea, representative's execution can, measures as far as change and quality. Itis otherwise called add up to profitable support, portrays an administration ways to deal withlong haul accomplishment through consumer loyalty (Henry and Adewale. 2013). By utilizingthis idea, all individuals from an association partake in enhancing forms, item, administrationsand the way of life in which they work (Total Quality Management 2016). Toward the end, onemight say that, It is a methodical strategy for the disposal of waste inside a generation frameworkin the organization. Organization can receive this technique with a specific end goal to limit thewastage of creation. 2 Objective of total quality managementTotal quality management is the colossal approach which guarantee that nature of itemsget kept up. Organization dependably need to give quality items to its shoppers so they feelfulfilled (Assarlind and Gremyr, 2016). This can be acquired through TQM process on thegrounds that by along these lines refered to firm will have the capacity to improve effectivenessof tasks and can have the capacity to component wastage from the framework. Add up to is theimmense application that can bolster in distinguishing circle fall in the framework and enhancingthese issues. On other hand changes in laws dependably make issue for the association to roll out
improvements in its tasks. The major objective of the total quality management application is toimprove the quality of the product and services by eliminate wastage and additional cost frommanufacturing and production procedure.3 Benefits of quality systemQuality framework techniques serves to change in organization's business, stock esteemand workers development . It is anything but difficult to gauge in various execution. Another preferred standpoint of this strategy is in increment the client esteem, it gives theconsumer loyalty by enhancing the activity fulfilment in workers of the organization. Quality framework system enhances the nature of execution in the business (Bo andet.al., 2015). It likewise advances the consumer loyalty by giving them nature of administrations in thebusiness. The real quality of this method to beat the blunder during the time spent administrationBy use of quality system within the production and manufacturing activities, companycan eliminate the additional wastages from the business and improve quality andefficiency of product and services.4 Steps of PDCAThe Plan- do- check- Act have major four stages for improve quality and effectiveness ofproduct and service. This technique is majorly use in the production and manufacturing activityand process for improve quality of services. Following are stages of this PDCA model-Plan- In this stage involves assessing a current process and new process. Company have to focuson what type of outputs that are desired to achieve. For address that outcome a systematic plancan develop by company.Do- The do phase allows the plan from the previous step. In this planning and developed strategygoing to implement in action. Company actually implement plan in the real action so as desiredoutcome can achieve (Jacobs, Swink and Linderman, 2015).Check- Once the action has taken by the company then in the next stage it is very important tocheck and monitor that action and activities.Act- In this stage, company again take action to improve the activities and outcome.
5 Hazard analysis and critical control pointsThis technique mostly used in the process of food safety and protection. It is a systematicpreventive approach to food safety from biological chemical and physical hazard in productionprocesses (Chaudary, Zafar and Salman, 2015). It assists to the users to overcome the uncertainhazard and risk from the food production so as high quality of food can deliver to the customers.It can be used at all stage of a food chain including packaging, distributions, production etc. Thissystem allow both industry and government to allocate their resource in auditing of safe foodproduction procedure.6 ICH objectivesThere are major three objectives of ICH Q10 that is achieved product realization, Establish andmaintain a state of control and facilitate continual improvement (Haider and et.al., 2015). Toachieve product realization is one of the major objective of ICH Q10 under which system allowsthe delivery of products with the quality so as patient requirement can effectively fulfill. Itimplements in the process for improve quality of service so s patient can improve their health.Another objective is to establish and maintain a state of control by which company caneffectively monitor the quality of services and process (Henry and Adewale. 2013). Quality riskmanagement can use to identify and monitor control system.7 FMEA and its area of use ?Implementation of FMEA in the process of production and manufacturing is to overcomeassociated hazard and risk and improve quality of product and services. In a general term it canbe said that Failure mode and effects analysis is a structured way to identify and acknowledgethe associated risk and hazard in the production and manufacturing (Haider and et.al., 2015). It isa effective in evaluating both new and existing process within the company. It is a structured wasto address the problem associated with the procedure through which quality and effectivenesscan automatically improve.8 Quality risk management for facilities and equipmentsThe main aim of quality risk management and equipment is to eliminate the unwanted risk andhazard from the business (Jacobs, Swink and Linderman, 2015). With help of this riskmanagement process, company can automatically overcome the hazard and uncertain hazardfrom the services and product. There are various kinds of process, equipment and facilities thatcan use by organization for improve the quality and overcome the unwanted hazard and risk
from the process. The most important aspect of risk management is to overcome uncertain riskfrom the process, product and services.9 Explanation about the corrective action and prevention actionThe corrective and preventive action is the improvement to an organization processestaken to eliminate causes of non conformity and other undesirable situation from theorganization. With help of this aspect uncertain hazard, risk and undesirable situation can easilyeliminate from the procedure (Assarlind and Gremyr, 2016). CAPA is generally used to beingimprovement and efficiency within the organization process, product and services through whichobjective can effectively address.10 The activities that should be conducted to mange and continuously improve thepharmaceutical quality systemThe process and product quality monitoring system includes several activities that are as follows-Use superior risk management to establish the control strategySupply the techniques for measurement and analysis of parameters (Assarlind andGremyr, 2016)Assessment if the parameters and attributes that is assessed in the control strategyIdentification of the sources of variation that affect process performance and productquality.In order to design space, it is provided knowledge and effective information.11 The objective of FDA guidance on quality system approach to pharmaceutical GMPregulationThe main objective of the FDA guidance on the quality system approach is to performingand handling test protocols with chronic protocols. It assists in enhancing the speed and qualityof the process. It is responsible to protect the public health by ensuring the safety, efficacy andsecurity of human and veterinary drugs, biological products and medical devices. It ensures thesafety of our nations food supply, cosmetics and products.12 Quality system modelsThe major aim of quality system model is to improve quality and effectiveness of the productand services in the organization and eliminate wastage and additional cost from production andmanufacturing procedure within organization. (Chaudary, Zafar and Salman, 2015) There arevarious kinds of the quality system model that is total quality management, six sigma, lean
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