por objetivo destacar aimportancia do assunto considerando que a implementacao pode ser realizadadentro de uma expectativa que possa atender as necessidades das empresas. Estaimplementacao tambem considera a introducao de processos de controle maisseguros, robustos e que tenham a capacidade de minimizar os riscos sanitariosinerentes ao processo de producao de medicamentos. A elaboracao de umaestrategia de implementacao deve seguir, obrigatoriamente, os requisitospreconizados nas atuais normas da ANVISA para a obtencao e renovacao deregistros dos produtos farmaceuticos, mas que ao mesmo tempo considere umaanalise global, segundo os aspectos de risco sanitario para a populacao,economico para a empresa e seguranca para a agencia reguladora. A publicacao daresolucao RDC No 60, de 10 de outubro de 2014, da um passo na direcao demaior regulacao nos estagios de desenvolvimento dos produtos, ja que esta deacordo com a implantacao de um sistema de garantia mais avancado, conforme sumariamentedescrito neste artigo.[1] Guidancefor Industry - ICH, Pharmaceutical Development, Revision 2, 2009.[2] Barretet al - A review or the use ofProcess Analytical Technology for the Understanding and Optimization ofProduction batch crystallization processes.[3] Guidancefor Industry PAT A Framework for Innovative Pharmaceutical Development,Manufacturing, and Quality Assurance[4] Menezes, et al, Tecnologiaanalitica de processo (PAT, process analytical technology) - aplicacoes naindustria farmaceutica e petroquimica.[5] Mei-Ling Chen, etall -Challenges and Opportunities in Establishing Scientific and RegulatoryStandards for Assuring Therapeutic Equivalence of Modified Release Products: WorkshopSummary Report[6] Cogdill, et al, Pharmaceutical Manufacturing Handbook: Regulations andQuality[7] LawrenceX. Yu, Pharmaceutical Quality by Design: product and processes development,understanding and control.[8] Kourti,Theodora, Process Analytical Technology Beyond Real-time analyzers: The role ofmutivariate analysis.[9] Gajardo & Reis Neto: O relacionamento entre o BSC e a gestao deprojetos.[10] Tese de doutorado- Marcos Viero Guterres, Analise multivariada em N-modos: metodologias para omonitoramento de reacoes quimicas.[11] Peinado;Hammond; Scott, J Pharm Biomed Anal. 2011 Jan 5;54(1):13-20. doi:10.1016/j.jpba.2010.07.036. Epub 2010 Aug 6., Development, validation andtransfer of a near infrared method to determine in-line the end point of afluidised drying process for commercial production batches of an approved oralsolid dose pharmaceutical product.[12] Sulubet al, 2009, Journal of Pharmaceutical and Biomedical Analysis 55 (2011)429434, Blend uniformity end-point determination using near-infraredspectroscopy and multivariate calibration.[13] Guenard;Thurau; 2005. Process Analytical Technology Spectroscopic Tools andImplementation Strategies for the Chemical and Pharmaceutical Industries Chapter 2 - Implementation of Process Analytical Technologies[14] Ritchie,Gary, Proceedings of the International Symposium, Cannes, 3-4 May 2004 Council of Europe A perspective and overview of Process Analytical Technology(PAT).[15] Roggo, Y., Chalus, P., Maurer,L., Lema-Martinez, C., Edmond, A., Jent, N., 2007. A review of near infraredspectroscopy and chemometrics in pharmaceutical technologies. J. Pharm. Biomed.Anal., 44, 683 700.[16] Sarraguca MC, Lopes JA (2009),Quality Control of Pharmaceuticals with NIR: From Lab to Process Line, Vib.Spectrosc., 49(2), 204-210 [doi:10.1016/j.vibspec.2008.07.013].[17] Laitinen, N.,Antikainen, O., Rantanen, J., Yliruusi, J., 2004. New perspectives for visualcharacterization of pharmaceutical solids. J. Pharm. Sci. 93, 165-176.[18] Moes, J.J.,Ruijken, M.M., Gout, E., Frijlink, H.W., Ugwoke, M.I., 2008. Application ofprocess analytical technology in tablet process development using NIRspectroscopy: Blend uniformity, content uniformity and coating thicknessmeasurements. Int. J. Pharm., 357, 108 118.[19] B.M.G. Vandeginste, D.L.Massart, L.M.C. Buydens, S. de Jong, P.J. Lewi, J.Smeyers- Verbeke, 1998.Handbook of Chemometrics and Qualimetrics: Part B. Elsevier Science, Amsterdam.[20] Blancoet