Continual Improvement Process. The Quality Manual is a tool for formatting of pharmaceutical product qualityprocess, which describes the activities performed within the organization, withsummarized presentation of all procedures, scripts, procedures, manuals,instructions and other documents approved in the productive area, that willform the basis of quality process and product organization. It includes: (a) Quality policy; (b) The purpose of Pharmaceutical Quality System; (c) Identification of Pharmaceutical Quality System and its processes, asits sequences, relationships and interdependencies; (d) Management responsibilitieswithin Pharmaceutical Quality System.Facilitators Pharmaceutical Quality Systemprovides two important tools. KnowledgeManagement (with product and process knowledge being managed from thedevelopment, during marketing product s life, including its withdrawal from themarket) is a systematic procedure for acquisition, analysis, storage anddissemination of information regarding the products, manufacturing processesand components. Quality Risk Management, an integral part of an effectivepharmaceutical quality system, can provide a propositional procedure for identification,scientific evaluation and control of potential risks to quality. It facilitatesContinual Improvement of process performance and product quality throughout itslife cycle, whose principles are provided by Guide ICH Q9. The elements described belowmay be required in part, under regional GMP regulations. However, Guide ICH Q10aims to be the highlight of these elements in order to promote Life Cycleapproach to product quality:o Process performance and product quality monitoringsystem; o Corrective action and preventive action (CAPA)system; o Change management system; o Management review of process performance andproduct quality. Figure 5 Interpretation ofconcept integrating of Guide ICH Q10 given by Jair Calixto Figure 5 explanation: the main blocks ofGuide ICH Q10 are: Pharmaceutical Quality System, Continual Improvement, ContinualImprovement of Pharmaceutical Quality System and Liability Management. Legend: PLC: Product Life Cycle. MLC: Managementof Life Cycle. KM: Knowledge Management. QRM: Quality Risk Management. QM: Quality Manual. CI:Continual Improvement. PQS: Pharmaceutical Quality System.(5) TOTAL QUALITY CONCEPT The set of stages throughout aproduct life from its conception to its withdrawal from market, ending itsperiod of production and marketing, is known as Life Cycle. As a step influences theother, talking about the quality of a product only makes sense if it is appliedto your entire Life Cycle. The foundation of Life Cycleis to design a product able to satisfy patients' needs and requirements thatwere specified, both physicochemical and pharmacological, and manufacturedfollowing a process in which the steps and operations have a scientific basis. In summary, you should:u Define product profile in relation to quality, safety and efficacy;u Identify product CQAs;u Identify parameters and quality specifications of Active Pharmaceutical Ingredientand excipients;u Set a robust and appropriate manufacturing process;u Identify the attributes of materials and critical process parameters;u Identify a monitoring and control strategy of critical parameters;u Determine functional relationships between attributes of materials andprocess parameters for Critical Quality Attributes.Figure 6 Graphic Representation of Q8, Q9, Q10System Integration, as interpretation given by Jair Calixto(6) CONCLUSIONS Theadoption of ICH guidelines mentioned in the text will contribute in an especialway the improvement in the control of medicine manufacturing, introducing newprinciples, new approaches and new concepts, as well as rescue concepts alreadyknown. New concepts like focus onpatient safety, the rescue of vision and action focused on ContinualImprovement, Quality Risk Management, Knowledge Management and decisions