{"id":274,"date":"2016-06-09T10:00:43","date_gmt":"2016-06-09T15:00:43","guid":{"rendered":"http:\/\/grupodesisa.mx\/blog\/?p=274"},"modified":"2016-06-09T21:11:35","modified_gmt":"2016-06-10T02:11:35","slug":"porque-del-apendice-b-normativo-para-la-rap","status":"publish","type":"post","link":"https:\/\/grupodesisa.mx\/blog\/porque-del-apendice-b-normativo-para-la-rap\/","title":{"rendered":"Porque del Ap\u00e9ndice B Normativo para la RAP"},"content":{"rendered":"<p><img decoding=\"async\" class=\"aligncenter size-full wp-image-276\" src=\"http:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2016\/06\/regulaciones-farmaceuticas-apendice-b-normativo.jpg\" alt=\"regulaciones-farmaceuticas-apendice-b-normativo\" width=\"100%\" height=\"auto\" srcset=\"https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2016\/06\/regulaciones-farmaceuticas-apendice-b-normativo.jpg 1000w, https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2016\/06\/regulaciones-farmaceuticas-apendice-b-normativo-300x200.jpg 300w, https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2016\/06\/regulaciones-farmaceuticas-apendice-b-normativo-768x511.jpg 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><br \/>\nEl Ap\u00e9ndice B Normativo, no debe de ser motivo de preocupaci\u00f3n (problem\u00e1tica) ya que existen diversas herramientas que le ayudaran a solucionar los retos que \u00e9ste representa para la industria farmac\u00e9utica y farmoqum\u00edca. Lo importante es estar conscientes de cu\u00e1nto tiempo disponen para implementar la soluci\u00f3n en su empresa.<\/p>\n<p><!--more--><\/p>\n<h3>El Ap\u00e9ndice B Normativo<\/h3>\n<p>&nbsp;<br \/>\nEl pasado 4 de febrero del 2016 se public\u00f3 en el DOF la NOM-059-SSA1-2015. Despu\u00e9s de esa fecha se tienen 180 d\u00edas para estar preparados y presentar la informaci\u00f3n que requiera la COFEPRIS o la autoridad sanitaria correspondiente en el momento que nos sea solicitada, independientemente del a\u00f1o del reporte RAP que se est\u00e9 presentando.<\/p>\n<p>En las normas anteriores a la 2015, la informaci\u00f3n se presentaba m\u00e1s por la interpretaci\u00f3n de los numerales que a lo verdaderamente solicitado, hoy con el nuevo formato dicha interpretaci\u00f3n se convierte en una solicitud literal de informaci\u00f3n. El <strong>ap\u00e9ndice B normativo<\/strong> es un formato establecido que no deja duda en cuanto a las secciones que le componen. Quiz\u00e1 habr\u00e1 quienes quieran mostrar m\u00e1s all\u00e1 de la informaci\u00f3n requerida, sin embargo no podr\u00e1 ser menos de lo especificado.<\/p>\n<p>Hoy por hoy, cada vez se agudiza m\u00e1s la forma en c\u00f3mo se revisan estas nuevas disposiciones, desde que se solicita expresamente que sea un <strong>proceso sistem\u00e1tico<\/strong> (numeral 5.9.1) as\u00ed como la informaci\u00f3n solicitada de los resultados de la RAP. Todo deber\u00e1n ser resumido en el formato que se especifica en el <strong>ap\u00e9ndice B normativo<\/strong> (numeral 5.9.2). Finalmente entre otros requerimientos debemos sumar la parte de la <strong>validaci\u00f3n<\/strong> de los procesos o <strong>herramientas sistem\u00e1ticas<\/strong> que utilizaremos para cumplir con la generaci\u00f3n del RAP (numeral 9.13.4.3).<\/p>\n<h3>RAPSys\u00a9 V2 Software para la revisi\u00f3n anual de producto<\/h3>\n<p>&nbsp;<br \/>\nUna de las <strong>herramientas sistem\u00e1ticas<\/strong> comprobadas desde su primera versi\u00f3n es el sistema RAPSys\u00a9 V2, que es un sistema que le facilitar\u00e1 el cumplimiento del proceso de la RAP en su empresa. Cumpliendo con el 100% de lo requerido en el Ap\u00e9ndice B Normativo y brindando beneficios adicionales como los es el mantenimiento del estado validado (numeral 9.14).<\/p>\n<p>Le invitamos a descargar y comprobar la funcionalidad del sistema <a href=\"http:\/\/www.grupodesisa.mx\/software-revision-anual-producto\">RAPSys\u00a9 V2  dando clic aqu\u00ed<\/a>. Ahi mismo podr\u00e1 conocer mas detalles y beneficios que el sistema le otorgar\u00e1 en su empresa.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>El Ap\u00e9ndice B Normativo, no debe de ser motivo de preocupaci\u00f3n (problem\u00e1tica) ya que existen diversas herramientas que le ayudaran a solucionar los retos que \u00e9ste representa para la industria farmac\u00e9utica y farmoqum\u00edca. Lo importante es estar conscientes de cu\u00e1nto tiempo disponen para implementar la soluci\u00f3n en su empresa.<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14,10],"tags":[28,11],"class_list":["post-274","post","type-post","status-publish","format-standard","hentry","category-industria-farmaceutica-en-mexico","category-rap","tag-apendice-b-normativo","tag-revision-anual-de-producto"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6.1 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Porque del Ap\u00e9ndice B Normativo para la RAP - Blog Desisa<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/grupodesisa.mx\/blog\/porque-del-apendice-b-normativo-para-la-rap\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Porque del Ap\u00e9ndice B Normativo para la RAP\" \/>\n<meta property=\"og:description\" content=\"El Ap\u00e9ndice B Normativo, no debe de ser motivo de preocupaci\u00f3n (problem\u00e1tica) ya que existen diversas herramientas que le ayudaran a solucionar los retos que \u00e9ste representa para la industria farmac\u00e9utica y farmoqum\u00edca. 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