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FDA Warns French Drugmaker Over GMP Concerns

Posted 07 May 2019 | By Michael Mezher 

FDA Warns French Drugmaker Over GMP Concerns

The US Food and Drug Administration (FDA) last month warned French drugmaker Laboratoires Clarins for good manufacturing practice (GMP) issues observed at the company’s Pontoise, France facility during an inspection in September.
 
The warning letter, which states that drugs manufactured by the firm are adulterated for failing to adhere to GMP regulations, lists three citations over issues related to the company’s handling of out-of-specification (OOS) test results, written procedures and sanitation issues.
 
According to FDA, Laboratoires Clarins failed to adequately investigate OOS test results for critical product attributes and did not institute effective actions to address the underlying issues in the future.
 
As such, FDA is requesting that the firm conduct an independent review of all OOS test results for products that were distributed to the US market and are within expiry and to create a corrective and preventative action (CAPA) plan to ensure its OOS investigations procedures are adequate.
 
FDA also says the company did not validate its processes for quality equipment used during the production of some of its drugs.
 
“Specifically, you did not perform process qualification studies, nor did you have a rigorous ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality,” FDA writes.
 
In response, FDA says the company must provide a validation plan for improving its process controls that includes a timeline for when it will conduct process performance qualification for each of its products.
 
Lastly, FDA says the Laboratoires Clarins’ cleaning and disinfection processes were not validated and were “limited to a visual examination of the surfaces to detect any contaminants.”
 
Going forward, FDA says the company must provide a comprehensive plan for its cleaning and disinfection procedures and provide an update on its cleaning and disinfection validation protocols. FDA also says the cleaning and disinfection validation protocols should factor in worst case scenarios, such as cleaning after manufacturing products with low solubility and disinfecting difficult to clean parts of equipment.
 
FDA

Categories: Regulatory News

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