RAPS: Drug Manufacturer Lacked Adequate Controls Over Manufacturing, FDA Warns

A Thailand-based active pharmaceutical ingredient (API) manufacturer has been warned by the US Food and Drug Administration (FDA) for failing to ensure that its manufacturing data could not be altered or falsified—claims similar to those levied against many Indian pharmaceutical companies. In a 27 February 2015 Warning Letter to Novacyl Ltd, FDA references an April 2014 inspection of the company\'s Samukprakam, Thailand manufacturing facility. There, FDA said it \"identified significant deviations from current good manufacturing practice (CGMP),\" the regulations enforced by FDA to ensure that products are produced under the proper manufacturing conditions. Some of the problems cited by regulators should be familiar to readers of recent Warning Letters targeted to other Asian manufacturers.

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