and that will keep the process operating asintended and desired, that is, as its DS. Figure 4 Interpretation of conceptintegrating of Guide ICH Q8 (R2) given by Jair Calixto Figure 4 explanation: Life Cycle managementis a period of time where DS coexists, consisting of QbD, where the product andits process are established using DoE tools in identifying CQAs. QRM applicationassists in identifying CCPs and CPPs. QbD has inter-relationship with PPP,which is monitored and improved through CI and MK. Legend: CQA: Critical Quality Attribute. DoE: Design of Experiments. PPP:Performance of Process and Product. DS: Space Design. KM: Knowledge Management.QRM: Quality Risk Management. CI: Continual Improvement. QPTP: Quality Profileof Target Product. CCP: Critical Control Point. CPP: Critical Process Parameter.QbD: Quality by Design. ICH Q9 Quality Risk Management GuideICH Q9 Quality Risk Management - deals with the risk and its propermanagement through tools that guide the user to adopt techniques ofdetermination, assessment and risk control. The risk analysis links the designof the manufacturing process to product quality. Theuse of risk analysis as a quality tool offers an effective assessment of thecentral points and of manufacturing processes and CCPs limits. Italso assesses safety of existing products through the integration of productsand processes design tools, using analysis of potential risks and an integratedquality management. Inproduct development, during the establishment of specifications and CQAs, it isrecommend the use of risk analysis tools for an evaluation of points andparameters subject to process control that will assist in security, efficiencyand product quality. Amongthe most important tools for risk analyses are: - FMEA: FailureMode Effect Analysis - FMECA: Failure Mode, Effects andCriticality Analysis -HACCP: Hazard Analysis and CriticalControl Points The purpose of using thesetools is to find CCPs, where the dangers are and where we should exercise effectivecontrol to eliminate them. Thesetools are included in the main mechanism of risk analysis, of Quality Risk Management (QRM), used to establisha product and its manufacturing process with quality, so as to provide theperformance of planned production. Thefundamental principles of risk analysis management are: i.The assessment of quality risk should be based on scientific information andfinally connect it to the patient protection; and ii.The level of effort, formality and process documentation of quality risk management should be commensurate with risk level. Possiblesteps used to initiate and plan a quality management process may include: Defining the problem and/or risk factor, including appropriate assumptions thatidentify potential risk; Gather prior information and/or data of relevant potential risks, danger or personalimpact for risk analysis; Identify a leader and necessary resources; Specification of term, results and appropriate level of decision-making forprocess of risk management.ICH Q10 PharmaceutialQuality System Guide ICH Q10 - Pharmaceutical Quality System - describes a model for aneffective system of quality management in the pharmaceutical industry, validfor all stages of Life Cycle and applicable both in the manufacture of ActivePharmaceutical Ingredients (APIs) and excipients, as in pharmaceutical products. The following components belongto ICH Q10: a. Quality Manual; b. Responsibilities ofmanagement towards quality; c. Establishing a quality policy (intentions regarding quality); d. Quality Planning (alignment with the company's strategic plans); e. Quality management (resources, communication, review, management); f.