(DoE), which promise to limit thenumber of required experiments. Knowledge Space- KSDesign Space DSNormal OperationSpace - NOSFigure 1 Demonstration of Design Space inKnowledge Space (adapted by Emil Ciurczak and Maria Teresa Cruanes) It can be observed that Design Space isa space larger than Normal Operation Space. Normal Operation Space has thesecurity of Design Space. Any change within Design Space is not consideredchanges in post-registration procedures. Moving out of Design Space assumes apost-registration regulatory process.Knowledge Space (KS): extensiveknowledge of the impact and interaction of input variables (material, process,environment) of CQAs products. Design Space (DS): range of conditions within KS which ensures thatthe product find CQAs. Normal Operating Space (NOS: operating range within DS that isapplied during manufacture routine. Although DS may be graphicallyrepresented, the ideal would be to establish a predictive mathematical model. Its important to rememberthat authorities do not require registration of Design Space. It's just onepossibility for registration applicant. DS main advantages are: A more robust process; Better knowledge of the product; Greater flexibility in production; Decrease in post-registration alterations; Increased confidence in product quality by regulatory authorities. EC is applicable to both newproducts as the old ones and all dosage forms, even the more complex, such as solid,are preferred.Continual Improvement Anotherimportant point is the implementation of Continual Improvement in manufacturingprocesses, systems, materials and products, maintaining a criticism routineaimed to evolution and increasinglyhigher comprehension of quality parameters. Theprocess of Continual Improvement is more than a work tool. It is a philosophyof quality, where the company, as a whole, is focused on improving itsprocedures, processes and products. This philosophy intends that people beprepared to evaluate, at any moment, the parameters that measure the quality,performance, productivity, costs, defects, failures, and especially customercomplaints. Ontable in Figure 2, there is a list of potential sources that contribute to ContinualImprovement of products: Source of Improvement External Audits Internal Audits Quality Deviations (related to GMP) Non-conformities Customer Complaints Gatherings Failures Out of specification results Periodic Product Review Figure 2 Table: Sources of Continual Improvement Precisely analyze customer complaints orcarefully investigate the faults and quality deviations leads the company toclimb steps toward improvement of product quality. All the points listed abovecan lead product improvement and its process. Figure 3 Graphicalinterpretation of Continual Improvement and its relationship with themanagement of Product Life Cycle given by Jair CalixtoManagement of Product Life Cycle TheManagement of Product Life Cycle is related to periodic review of both product andprocess to ensure its operation as established in the project, complying withthe attributes of product quality. The different stages of product Life Cycle are summarizedin four steps: - ThePharmaceutical Development -The Technology Transfer -The Commercial Manufacturing -The Product Discontinuation DS may provide flexibilitythat can optimize and adjust the process in accordance with the management ofyour quality system, as an DS is not necessarily static in nature. Guidelines ICH Q8 (R2) provideencouragement to the use of risk analysis tools, which help companies toestablish the mentioned CQAs, pointing and determining, through a formal, criticaland systematic process, the Critical Control Points (CCPs ). CCPs reportspoints where control interventions are needed, and more precisely establishparameters that will be controlled