basedon scientific knowledge will change the way companies and professionals will controland manage the processes and pharmaceutical products. This new form of management beginsin development and continues throughout product life throught: (1) identification of the patients needs; (2)identification and mitigation of risks related to process and product; (3)scientific decisions during Life Cycle, in order to keep the process undercontrol to eliminate the health risk to the patient. As thesenew approaches will reach more and more countries, it makes sense to recommendthat efforts be directed toward the global harmonization of regulationsimplicit in these guidelines as a mechanism for standardization of GMP, GMPcertifications and inspections related to them. Other harmonization related to specificationsand on quality control methodologies are also, equally necessary. (7) REFERENCES BOTET, Jordi. Sistema de Calidad Farmaceutica Del Siglo XXI. RCN, 2008.CIURCZAK, Emil W. Workshop ManufacturingInitiative for the 21st Century. QbD Overview. Sao Paulo: SINDUSFARMA, jun. 2010._______________. Workshop GMPfor the 21st Century - FDA initiative. Sao Paulo: SINDUSFARMA, jun. 2010.CRUANES, Maria Teresa. Workshop Manufacturing Initiative for the 21st Century. QbD Overview. Sao Paulo: SINDUSFARMA, jun. 2010.International Conference on Harmonization ofTechnical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. ICH Q8 (R1) Desenvolvimentode Produtos. Versao vigente da Etapa 4, datada de 10 denovembro de 2005.____________________.ICH Q9 Quality Risk Management - U.S. Department of Health and Human Services- Food and Drug Administration, Center for Drug Evaluation and Research (CDER),Center for Biologics Evaluation and Research (CBER), June 2006, ICH.____________________. Pharmaceutical Quality System Q10. Current step 4 version, 4 June 2008.____________________. PharmaceuticalDevelopment Q8 (R2). Current step 4 version, August 2009.MORETTO, L. D.; CALIXTO,J. Diretrizes para o Gerenciamento deRiscos nos Processos da Industria Farmaceutica. Sao Paulo: SINDUSFARMA,2011. volume 13. ______________________. Estrutura do Novo Sistema da Qualidade. Sao Paulo: SINDUSFARMA, 2011. volume 5.1. U.S. Department of Health and Human Services. Food and Drug Administration. Guidancefor Industry. PAT A Framework for Innovative Pharmaceutical Development,Manufacturing and Quality Assurance. Center for Drug Evaluation and Research(CDER), Center for Veterinary Medicine (CVM), Office of Regulatory Affairs(ORA), Pharmaceutical CGMPs, September 2004.ZARDO, Humberto. Workshop Sistema de qualidade farmaceutica aplicando desenho, analise de riscose monitoramento - Uso de ICH Q8, Q9, Q10 & CGMP XXI Century. Sao Paulo:SINDUSFARMA, 2008. _______________. Texto Gerenciamentode riscos: do desenvolvimento de produtos a cadeia de distribuicao. Rev. 2, maio 2010. *Minicurriculum - Jair CalixtoManagerof Good Practices and Pharmaceutical AuditPharmacist-Biochemistry majored in 1985 by Faculty ofPharmaceutical Sciences at University of Sao Paulo (FCF-USP), inIndustrial Business in 1992 by Vanzolini Foundation at Poli USP Master inBusiness Administration from FGV in2004.In 1972, he began his career in marketing Pharmacy. Aftergraduating from FCF-USP, worked in the pharmaceutical industry, where he workedin Quality Assurance, Quality Control, Production and Product Development areas.He is currently Manager of Good Practices andPharmaceutical Audit at SINDUSFARMA - Union of Pharmaceutical Industry in Stateof Sao Paulo, where he is responsible, among other, for coordinating theworking groups on Public Consultation at ANVISA of technical-regulatory area, internationaltechnical workshops, developtechnical books and coordinate Sindusfarma Analytical Quality Award andSindusfarma Quality Award of Industry Supplier. **Minicurriculum - Dr. Lauro D. MorettoExecutiveVice-PresidentVice President of Sindusfarma, President of National Academy of Pharmacy. Pharmacist-Biochemistry,with a Masters