印度的压力：GMP符合性不能保证在许多API设施

清歌一曲月如霜

在印度的压力越来越大，因为在检查中发现的GMP缺陷。广泛的FDA的警告信及美国FDA进口警示会给予特别关注。观察了GMP偏差是极端的，令人震惊的部分就为病人的潜在风险。甚至小学GMP要求却被忽略了。生产区往往在一个不受控制的状态（交叉污染的风险）的药品必须召回找到。警告信的Wockhardt公司是最突出的例子之一。根据发表在RAPS在线的一篇文章，美国FDA检查员在写这封信有关的位置： “广泛的令人不安的指控，包括浴室，允许为站立小便收集地板上，产品受污染的玻璃和未知的”黑色颗粒， “工作人员反复骗了美国FDA在多个场合，并且被保存着从研究者的生产线。 ”
与此同时，这表明在印度有效和广泛的GMP监测是不存在的。该通讯社路透社的一篇文章总结了该主题令人印象深刻的信息。根据它， 1,500检查员负责10,000工厂。在一个每22个样品中，缺乏质量已被观察到。这些数据来自于已经执行了两年前的一项研究。
路透社引用行业分析师谁说，公司不能提供，因为一个进口警报到美国可能会继续生产和销售他们的产品，这是不知道的那些GMP缺陷等国家。这是一个可怕的情景是 - 根据专家报告 - 在印度的现行做法。因为在印度的监测医药产品根本不足以如此严重的问题，只能解释。一个符合GMP检查员在印度对路透社记者说： “我拿了工资30年没有做任何事情，我访问了一些工厂......不采取任何行动的意图，但只是出于好奇。 ”路透社援引印度卫生部雇员谁说，只有美国FDA抱怨印度的工厂。 “ （ ... ）其他国家都没有问题，我们的药物，他们从未提出过异议或发现故障， ”这种说法可以很容易反驳。该EudraGMDP数据库目前列出38设备在印度被归类，因为负面的GMP检查为“GMP不符合规定” 。
充足的GMP监管（ GMP检查）由印度当局的缺乏也提出了对欧盟的程序，以书面要求（GMP ）的确认来自世界各地的机构问题。为了从位于欧盟以外的制造商导入一个API的法律规定要求书面确认必须由出口国出具的（只有一些国家，如如瑞士，美国已发现有相同的GMP检查制度和不需要发出书面确认） 。印度已经发表了许多书面确认，对原料药生产厂家在印度。然而，一些谁拥有书面确认公司获得FDA的警告信或发出的书面确认，只有一些个月后，欧盟GMP违规发言。这种质疑的书面确认的价值也为印度的所有其他设备通过欧盟或美国FDA检查员没有最近检查。路透社， RAPS在线和其他公认的媒体资源发布的信息可能需要启动按行业和监管机构在欧盟其他操作，以保障从印度进口的API。


The pressure on India is getting bigger because of GMP deficiencies found during inspections. A wide range of FDA Warning Letters and FDA Import Alerts are given special attention. The GMP deviations observed are extreme and partly alarming with regard to the potential risks for the patients. Even elementary GMP requirements have been neglected. Production areas were often found in an uncontrolled status (risk of cross contamination) that medicinal products had to be recalled. The Warning Letter for Wockhardt is one of the most prominent examples. According to an article published in RAPS Online, FDA inspectors wrote in this letter about the location: "a wide range of disturbing allegations, including bathrooms that allowed for the collection of standing urine on floors, products contaminated with glass and unknown "black particles," staff that repeatedly lied to FDA on multiple occasions, and manufacturing lines that were kept hidden from investigators."
At the same time, this shows that effective and extensive GMP monitoring in India is inexistent. An article of the news agency Reuters summarised impressive information on the topic. According to it, 1,500 inspectors are responsible for 10,000 factories. In one out of every 22 samples, lack of quality has been observed. These data come from a study already performed two years ago.
Reuters refers to industry analysts who say that companies which cannot deliver into the USA because of an Import Alert might continue their production and sell their products to other countries which are not aware of those GMP deficiencies. This is a terrifying scenario which is - according to experts' statements - current practice in India. Such serious problems can only be explained because of totally insufficient monitoring of medicinal products in India. A GMP inspector in India told Reuters: "I took salaries for 30 years without doing anything. I visited some of the plants ... not with the intention of taking any action, but just out of curiosity." Reuters quotes an employee of India's health ministry who says that only the US FDA complains about Indian factories. "(...) other countries have no problems with our drugs. They have never raised any objections or have found fault," This statement can be easily refuted. The EudraGMDP database currently lists 38 facilities in India which have been classified as "GMP non-compliant" because of negative GMP inspections.
The lack of adequate GMP supervision (GMP Inspections) by Indian Authorities also raises questions on the EU procedure to require Written (GMP) Confirmations from agencies around the world. In order to import an API from a manufacturer located outside the EU the legal provisions require that a Written Confirmation has to be issued by the exporting countries (only some countries like e.g. Switzerland, USA have been found to have equivalent GMP Inspection systems and do not need to issue Written Confirmations). India has published many Written Confirmations for API manufacturers in India. However, some of the companies who own a Written Confirmation received FDA Warning Letters or EU GMP non-compliance statements only some months after the Written Confirmations were issued. This questions the value of the Written Confirmations also for all other facilities in India not inspected recently by EU or FDA inspectors. The information published by Reuters, RAPS Online and other well recognized media sources may require to initiate additional actions by industry and regulators in the EU in order to safeguard APIs imported from India.

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