巴西醫療器械質量體系要求

巴西醫療器械質量體系要求(BGMP驗廠)

巴西醫療器械質量體系要求(BGMP)由RDC16:2013規定,該法規的內容類似于ISO13485及美國的QSR820,但細節上也有很大差別,如RDC16特別調工作環境、風險管理等方面的要求。 

B-GMP概述

--申請III、IV類器械ANVISA注冊的制造企業,必須通過BGMP認證(驗廠);

--BGMP由ANVISA具體實施,每2年檢查一次;

--其審查費遠高于歐盟的CE認證費;

--在提交ANVISA認證時提出BGMP審廠申請,進入巴西衛生部排隊系統;

--由于巴西衛生部巴西衛生部的人手有限,相關手續非常復雜,等候審廠的周期有時會長達兩年之久,有的申請者甚至通過法院起訴才贏得審廠機會。

我們的服務

No.階段項目內容
1初步調研了解企業現狀,特別是企業最關注的問題和薄弱環節。
2詳細診斷詳細審查現有文件與現場,提出可操作的整改意見。
3培訓BGMP的理解和實施,BGMP與ISO13485的區別與聯系; 
其他與產品和過程相關的標準培訓。
4一期整改方針、目標、機構、職責、全套流程的整改。
5二期整改操作整改:操作程序的執行與記錄整理。
6內審與管審參與進行內部審核和管理評審。
7三期整改落實內審和管審發現的問題。
8模擬審查模擬BGMP驗廠。
9四期整改糾正模擬驗廠不合格項,迎接BGMP驗廠。
盛大乐彩 WWW.398012.COM|WWW.336021.COM|WWW.334657.COM|www.88266f.com|WWW.589820.COM|WWW.81416.COM|www.41518k.com|WWW.908226.COM|WWW.533050.COM|www.57578f.com|WWW.520637.COM|WWW.683448.COM|www.ac9922.com|WWW.333442.COM|www.268221.com|WWW.877715.COM|www.936370.com|WWW.804401.COM|www.84499c.com|WWW.495080.COM|www.743633.com|www.3005.am|WWW.755486.COM|www.526031.com|www.axc4.com|WWW.573206.COM|www.273215.com|WWW.449988.COM|www.976281.com|www.8039p.com|WWW.521422.COM|www.713667.com|WWW.400439.COM|WWW.140045.COM|www.71233s.com|WWW.687613.COM|www.817824.com|www.669zf.com|WWW.181258.COM|www.327526.com|WWW.930041.COM|WWW.330370.COM|www.c2656.com|WWW.388438.COM|www.77803e.com|WWW.640004.COM|www.541638.com|WWW.645234.COM|www.937299.com|WWW.116780.COM|WWW.912058.COM|www.71399j.com|WWW.501952.COM|www.68682o.com|WWW.727903.COM|www.99788b.com|WWW.575954.COM|www.203552.com|WWW.798013.COM|www.606285.com|www.hm6633.com|WWW.840181.COM|www.5091k.com|WWW.381802.COM|www.78949y.com|WWW.114292.COM|www.50064d.com|WWW.366888.COM|www.00840s.com|WWW.517886.COM|www.77114u.com|WWW.363643.COM|www.52072s.com|WWW.719234.COM|www.5441r.com|WWW.556448.COM|www.yi876.com|WWW.35222.COM|www.36166a.com|WWW.179333.COM|www.hcw776.com|WWW.60486.COM|www.84499k.com|WWW.322438.COM|www.187135.com|WWW.523262.COM|www.87668x.com|WWW.78952.COM|www.26299c.com|WWW.617506.COM|www.61233d.com|WWW.18451.COM|www.6364h.com|WWW.606968.COM|www.c229.net|www.881809.com|www.zch4.com|www.977389.com|WWW.15368.COM|www.808910.com|WWW.538011.COM|www.508433.com|WWW.890141.COM|www.550435.com|WWW.905452.COM|www.177804.com|WWW.315062.COM|www.621431.com|WWW.140029.COM|www.202427.com|WWW.879835.COM|www.60108q.com|WWW.112247.COM|www.2632q.com|WWW.561066.COM|www.1999ac.com|WWW.737083.COM|WWW.709928.COM|www.770640.com|WWW.662628.COM|www.802733.com|WWW.343201.COM|www.504033.com|WWW.329383.COM|www.687044.com|WWW.269555.COM|www.199301.com|WWW.614708.COM|www.33997w.com|WWW.614708.COM|www.9478h.com|WWW.310211.COM|www.hc3656.com|www.890992.com|WWW.589820.COM|www.330265.com|WWW.420850.COM|www.97655g.com|WWW.518956.COM|www.2934h.com|WWW.707339.COM|WWW.645845.COM|www.599439.com|WWW.519790.COM|www.025532.com|WWW.872009.COM|www.9818k.cc|WWW.16405.COM|www.07163n.com|WWW.622501.COM|www.c6881.com|www.679822.com|www.cf9909.com|www.802933.com|WWW.362790.COM|www.101372.com|WWW.841609.COM|www.33112v.com|WWW.111708.COM|www.99jtk.com|WWW.777832.COM|www.hczx4.com|www.810612.com|WWW.15207.COM|www.791397.com|WWW.222098.COM|www.115669.com|WWW.552096.COM|www.6364x.com|WWW.553025.COM|WWW.502703.COM|www.505420.com|WWW.591020.COM|www.411515.com|WWW.225570.COM|www.097079.com|WWW.638522.COM|www.22ckb.com|www.937065.com|WWW.910046.COM|www.109026.com|WWW.150957.COM|www.3890t.com|WWW.823746.COM|WWW.773737.COM|www.372879.com|WWW.420850.COM|www.26299q.com|WWW.207607.COM|WWW.462543.COM|www.368477.com|WWW.655538.COM|www.43131j.com|WWW.388506.COM|www.yi328.com|www.865065.com|WWW.303457.COM|www.89894s.com|WWW.633950.COM|WWW.725350.COM|WWW.767744.COM|WWW.14106.COM|www.364242.com|www.003ac.com|www.955484.com|WWW.426225.COM|www.178763.com|WWW.576309.COM|www.1368x.cc|www.927035.com|WWW.124545.COM|www.96386d.com|WWW.130448.COM|www.hr1888.com|www.810513.com|WWW.701125.COM|www.49956o.com|WWW.46166.COM|www.c6091.com|www.621319.com|WWW.336678.COM|www.268221.com|WWW.631680.COM|www.061wy.com|www.807835.com|WWW.393742.COM|www.99djcp.com|WWW.269057.COM|WWW.259330.COM|www.407869.com|WWW.642624.COM|www.2350d.com|www.856659.com|WWW.754208.COM|www.79520b.com|WWW.49481.COM|WWW.147876.COM|www.316546.com|WWW.618475.COM|www.hm2555.com|www.771219.com|WWW.133050.COM|www.66026.cc|WWW.298309.COM|WWW.345037.COM|www.83033n.com|WWW.175293.COM|WWW.915528.COM|www.621764.com|WWW.585772.COM|www.86267u.com|WWW.797744.COM|WWW.332962.COM|www.186757.com|WWW.240979.COM|WWW.383897.COM|www.355811.com|WWW.475318.COM|www.hy6939.com|www.546599.com|WWW.635005.COM|www.1035u.com|www.749996.com|WWW.24366.COM|www.09559.cc|www.915655.com|WWW.322589.COM|www.33997b.com|WWW.741183.COM|WWW.538845.COM|www.65707p.com|WWW.832308.COM|WWW.27518.COM|www.99677m.com|WWW.435432.COM|www.c6348.com|www.513477.com|WWW.930060.COM|www.hx8866.com|www.550164.com|WWW.912966.COM|www.ya160.com|www.645411.com|WWW.477782.COM|www.6364x.com|www.684050.com|WWW.260340.COM|www.5095h.com|www.669268.com|WWW.735898.COM|www.5086m.com|www.805462.com|WWW.56265.COM|www.32123h.com|WWW.272629.COM|WWW.786989.COM|www.08588h.com|www.965666.com|WWW.802969.COM|www.54400s.com|WWW.257330.COM|WWW.690566.COM|www.68689x.com|WWW.490035.COM|WWW.675053.COM|www.77996d.com|WWW.870147.COM|WWW.346255.COM|www.32123g.com|www.938537.com|WWW.362355.COM|www.43818.com|www.892070.com|WWW.162337.COM|www.371d.cc|www.605134.com|WWW.655985.COM|www.fcff4.com|www.440689.com|WWW.606997.COM|WWW.55088.COM|www.271051.com|WWW.94521.COM|WWW.10212.COM|www.77114u.com|WWW.784563.COM|WWW.253940.COM|www.07163n.com|www.652392.com|WWW.909964.COM|WWW.666199.COM|www.143552.com|WWW.297799.COM|WWW.311386.COM|www.26163t.com|www.791571.com|WWW.145336.COM|WWW.64146.COM|www.322918.com|WWW.217552.COM|WWW.908726.COM|www.60007b.com|www.889688.com|WWW.273761.COM|WWW.29937.COM|www.186126.com|WWW.355320.COM|WWW.221879.COM|www.80065q.com|WWW.272629.COM|WWW.403046.COM|www.ct8822.com|www.206882.com|WWW.72108.COM|WWW.306727.COM|www.68682m.com|www.954688.com|WWW.121957.COM|www.okw2.com|www.322424.com|