expanding ranges ofspecifications and CCPs through the use of modern techniques such as Design ofExperiments.Decisions Based on Scientific KnowledgeRescueattitudes based on science, rather than empirical attitudes, with no scientific basis.Decisions on quality through the use of goodscience.Establishment of standards and specifications using risk analysis. Theadoption of these concepts will bring, as an immediate consequence, severaldirect and indirect benefits to product, patient and company, the mostimportant:strengthen product quality;increasing patient safety;improvement in company's image;increase in employee morale;process robustness;reduction of quality deviations and post-registration changes;reduction in the number of complaints and returns;recognition or increase in perceived product quality. Other indirect benefits may also be related when analyzing ICH guidelines.2nd aspect: Global Harmonization Harmonization of Good Manufacturing Practices technicalrequirements; Harmonization of pharmacopoeialspecifications; Harmonization of inspection for the purposeof GMP certification; Standardization of regulations that affectproduction and medicines control on a global level; Improving medicines quality on a global level; Facilitating medicine marketing; Integration of various internationalregulatory agencies; Uniformity in combating fraud in medicines; Improving access to medicines in differentcountries; Establishment of unique requirements fortraceability and authenticity of medicines; Implementation of procedures for mutualrecognition of GMP certification betweendifferent regulatory agencies.4. MAIN GUIDE CONCEPTS ICH Q8 (R2) PharmaceuticalDevelopment One of the concepts on the Guide ICH Q8(R2) is the establishment of quality in medicine development, attributing highimportance of correctly setting the specifications and Critical QualityAttributes (CQAs) of active pharmaceutical ingredient and finished product,with implicit qualification and suppliers evaluation of critical components. Inthe universe of raw materials, it becomes necessary suppliers qualification, whereare evaluated their quality system, adherence to the specifications and to the customerquality system, the treatment that is given to the need of Continual Improvementof their processes, how they resolve customer complaints, through a formalinvestigation of deviations and gaps, and how they apply corrective, preventiveand contingency actions (CAPA System = "CorrectiveAction, Preventive Action") required. Quality by Conception (Quality by Design)e Conception Space (Design Space) Qualitymust be planned since the design of the product. Thus, Guide ICH Q8 (R2)introduces a new model for achieving quality, which is through a process calledQuality by Design (QbD). Quality byDesign is part of a larger and more complex universe, the Design Space (DS). Therefore,the quality should be established during the product design using the Design Spaceand its tools as a field of work. Tobetter understand this topic, it is necessary to explain the importance ofvariables. The critical variables of inputs and Critical Process Points (CPCs)must be known to avoid they adversely affect CQAs of final product and,consequently, product quality. Two approaches are acceptablefor this: - The first, more simple andtraditional, is to establish the acceptable allowable range for each critical variable.Product quality is maintained to the extent that the variables remain withinthe range. - The second is the DS. Theaim is to integrate all the information (input variables, process parametersand finished product specifications) in a space in which all the essential CQAsare satisfied and where, consequently, product quality is assured. EC determination requires todevelop a major research work, because it supposes to submit to test variationsbehavior in face of the variations of each one. Therefore, statisticaltechniques are used for Design of Experiments