Regulatory Focus™ > News Articles > WHO: Prequalified Drugs Made at Mylan's Nashik Site do not Raise Quality Concerns

WHO: Prequalified Drugs Made at Mylan's Nashik Site do not Raise Quality Concerns

Posted 02 June 2017 | By Michael Mezher 

WHO: Prequalified Drugs Made at Mylan's Nashik Site do not Raise Quality Concerns

The World Health Organization Prequalification Team (WHO-PQT) said this week that it is no longer concerned about the quality of prequalified products made at Mylan Pharmaceuticals' Nashik, India site after the US Food and Drug Administration (FDA) warned the site over quality system issues in April.


FDA's warning letter raised fears that a suspension of production at the site, which produces 21 WHO-prequalified antiretroviral drugs used to treat HIV/AIDs, could lead to an interruption in the supply of those drugs to low- and middle-income countries (LMICs) that rely on WHO prequalification for national procurement.

However, at the time, a Mylan representative toldFocus that production at the site "continues uninterrupted" and that the company did not foresee any supply issues for products being made at the site.

In the FDA warning letter, the agency said the site did not have a functioning quality system and that the company failed to monitor and investigate error signals generated by its computerized systems used for high performance liquid chromatography and gas chromatography.

FDA also noted that Mylan attributed the error signals to "numerous … power interruptions, connectivity problems (disconnection of the Ethernet or power cord), and instrument malfunctions."

Following the FDA warning letter, WHO advised procurers to be extra vigilant when purchasing prequalified products from the Nashik site and requested that Mylan provide an impact assessment of the inspection observations and conduct "comprehensive testing" to ensure product quality.

WHO Assessment

Now WHO says the impact assessment provided by Mylan has eased its concerns over potential quality problems as a result of the issues cited in FDA's warning letter.

"Based on the … impact assessment, WHO-PQT concludes that the observations in the US FDA warning letter do not raise concerns regarding the quality of the WHO prequalified products," WHO said, noting that it would be inspecting the site "in due course".

The agency also notes that it has not received any complaints relating to the quality of prequalified products produced at the Nashik site in the last two years.

According to WHO, Mylan's impact assessment showed that the company's analytical methods related to the 21 prequalified products were validated before being transferred to the Nashik site and that the method validations were completed before releasing any WHO prequalified products.

WHO also says that Mylan ran a simulation to show that it would not lose data in its audit trail due to disconnected power cables, and that the simulation was independently verified.

Additionally, WHO says that Mylan appropriately handled out of specification (OOS) results related to the prequalified products.



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