India under Pressure: GMP Conformity Not Guaranteed in many APIs Facilities

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India under Pressure: GMP Conformity Not Guaranteed in many APIs Facilities

The pressure on India is getting bigger because of GMP deficiencies found during inspections. An article of the news agency Reuters summarised impressive information on the topic. Read more here about the Reuters article.

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http://www.gmp-compliance.org/enews_4294_India%20under%20Pressure%3A%20GMP%20Conformity%20Not%20Guaranteed%20in%20many%20APIs%20Facilities_8500,S-WKS_n.html

India under Pressure: GMP Conformity Not Guaranteed in many APIs Facilities

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…

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