IPCA进口禁令引起的数据完整性思考

julia朱玉姣

Data Integrity - Again Import Alert issued for Indian company IPCA

数据完整性---FDA签发印度公司IPCA进口禁令

Data Integrity has become one of the most important GMP compliance issues in past two years. This has enormous consequences for the concerned companies but also for companies and authorities in EU and US. It was the US FDA that has first experienced huge data integrity problems in companies worldwide. Many sites in India have been found to violate GMP requirements by Data Integrity issues. Tests have been repeated and original data have been deleted. This is called "testing into compliance". At the Webpage of the US FDA IPCA products are listed which are impacted by the Import Alert. Two facilities from IPCA have been found to be out of GMP compliance: One in Pithampur (Madhya Pradesh) and one in Piparia (Silvassa) (see also report by FiercePharma).

数据完整性在过去2年已经变成了最重要的GMP符合性问题之一，它不仅给很多相关企业带来恶果，也给欧盟和美国的企业和药监局带来问题。美国FDA经历了全球范围内药企巨大的数据完整性问题。印度的许多工厂已被发现在数据完整性问题上违反了GMP要求，重复检测及原始数据被删除。这被称为“检验至符合”。在美国FDA网站上，IPCA公司受到进口禁令影响的产品被列出，IPCA的2个工厂被发现不符合GMP要求。一个在PITHAMPUR，另一个在PIPARIA（参见FIERCEPHARMA报道）。

Products manufactured at those facilities might cause high risks to patients. The quality of the products can not be specified because the original test data were simply deleted. The company IPCA was already known for not meeting the GMP requirements. Already in July 2014 IPCA halts US shipment from the Ratlam plant after FDA found massive GMP violations. As a consequence the Canadian Authority (Health Canada) has banned a huge list of APIs and medicinal products from their market as well. Now they have informed the Bombay Stock Exchange about their problems (see message regarding Import Alert issues by IPCA)

在这些工厂生产的产品可能会导致患者高度风险。产品质量可能不符合质量要求，因为原始检测数据就那么被删除了。IPCA公司已经知道这是不符合GMP要求的。在2014年7月，在FDA发现其大量GMP违规行为后，IPCA公司从RATLAM工厂出口至美国的货物被叫停。由此，加拿大官方（加拿大卫生局）已禁止该公司大量原料药和制剂在加拿大销售。现在，IPCA公司通知孟买证券交易所其所遇到的问题（参见关于IPCA被签发进口禁令的消息）。

But what are the consequences for companies and authorities in Europe and the US? Authorities might be asked why the same facilities that have been found to be involved in the falsification of data are still allowed to supply to EU patients. For example IPCA is still listed with a GMP certificate for the concerned facilities in EudraGMDP. And EU and US companies need to check very carefully which supplier, partners and own sites they have in India. Quite a few companies have been found to delete data and to perform testing into compliance. FDA has started to check whether companies have checked their suppliers for data integrity. The MHRA has put this on the agenda for their inspections as well.

但在公司及欧美药监后面会怎么样呢？药监可能会被追问为什么该工厂已被发现伪造数据，但仍还被允许向欧盟患者销售其药品。例如，在EUDRAGMDP数据库里，IPCA的证书还列在里面。欧美公司需要非常仔细地检查其在印度的供应商、合作伙伴及其自己在印度的工厂。只有少数公司被发现删除了数据，检测直至合格。FDA已开始检查是否有公司对其供应商展开数据完整性检查。MHRA也已将该主题放在其检查日程中。

syhorchid

删除数据也属造假

道路漫长黑暗

感觉这个问题不能局限在QC考虑，首先是生产有需求，然后才是检测直至合格。

红叶舞秋山

谢谢分享啊