Adoption of ICHGuidelines Q8, Q9 and Q10:a real need today *Jair Calixto**Lauro D. Moretto1. INTRODUCTION Throughout XXcentury, the notion of quality has undergone three major modifications. Itstarted with the old concept of "analyzed quality" i.e., completingthe manufacturing process; the excellence of a product was determined byanalysis. However, as there were many drawbacksof this approach (both logistical and technical), in the middle of the centuryit was replaced by the idea of "manufacturedquality".Theessential was to define a manufacture a procedure that would work, and thenrepeat it exactly the same way. The process validation was the resource used toverify that effectively had a process in place to get the product. The analysiswas restricted to a secondary role. At the end of XX century, the notionthat quality should be "manufactured" arises, but only after havingbeen "conceived". The concept is that a poorly designed product isunlikely to have quality, even if it is manufactured and analyzed under thebest quality concepts. The new philosophy establishes the concept that qualityis initially designed (in product, in process and in control) and then ismanufactured, controlled and evaluated, which is known as "global or integratedquality." 2. NEW INITIATIVES In August 2002, the Foodand Drug Administration (FDA) announced a new initiative known as "FDA Pharmaceutical cGMPS for the 21 century arisk-based approach. The intention wasnot to propose new GMPs, but interpret them in a more "modern" and "scientific"manner. In the international scope of thisinitiative developed by the InternationalConference on Harmonization of Technical Requirements for Registration ofPharmaceuticals for Human Use (ICH) are government agencies and industryassociations from the United States,European Union and Japan. ICH has no regulatory autonomy. Asa result, developed and approved guidelines have been internalized by FDA (United States), EMA (European Union) and PMDA (Japan).ICH Q11 document is still in draft phase.IMPORTANCE OF THE ADOPTION OF THE NEW QUALITY SYSTEM ICHguidelines reflect the new thinking about the quality of medicines in the worldand, as already demonstrated above, it was internalized in Japan, U.S.and Europe. As Brazil has not taken thisinitiative yet, it is important that these guidelines are incorporated into theregulatory framework, so that companies and professionals interested may learnand study them.The future manufacturing procedures, control and medicine marketing willhave to base on these new guidelines, which should bring great benefits to companies,beyond those intrinsic to Guides, mainly addressed to patients. The various reasons whythe guidelines will bring greater agility and safety to procedures may beextracted in these Guides, when performing a deeper analysis. We may classifythem into two areas: Quality and Global Harmonization. 1st aspect:QualityChange from Product-Based Focus to Patient-Based FocusThegreatest interest is to achieve the desirable requirements for patients, providing them security in medicine use. Continual ImprovementEstablishpolicy and philosophy. Ongoing effort to improve process, product and services.Risk Management Transientestablishment of control points based on prior knowledge, history andperception to risk analysis associated with each process step. Knowledge ManagementPersonal: managing personalcompetences acquired and enable continued development.Product: specific learning to each registered productthroughout its Life Cycle, serving as a tool for Continual Improvement.Regulatory flexibilityImplement mechanisms that provide theindependence of the process. Proven and Extended Work RangesEnsuringproduct quality and drastically reduce quality deviations,