Data Integrity – Again Import Alert issued for Indian company IPCA…http://www.gmp-compliance.org/enews_04789_Data-Integrity—Again-Import-Alert-issued-for-Indian-company-IPCA_9193,S-QSB_n.html
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).
Products manufactured at those facilities might cause high risks to patients. The quality of the products…
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