update

Ireland's HPRA did not recommend GMP cert renewal for Wockhardt Shendra plant

By Gareth Macdonald contact

- Last updated on GMT

iStock/G0d4ather
iStock/G0d4ather
The Health Products Regulatory Authority of Ireland (HPRA) has said it did not recommend renewal of the GMP certificate for Wockhardt’s site in Shendra, Aurangabad.

Indian drug manufacturer Wockhardt claimed the HPRA had recommended the site's good manufacturing practice (GMP) certificate be renewed in a document​ filed on the Bombay Stock Exchange (BSE) yesterday. 

The firm said: “The Health Products Regulatory Authority of Ireland has inspected our Shendra, Aurangabad facility and have recommended the renewal of certificate based on the general compliance with the principles and guidelines of Good Manufacturing Practice​.”

We reported the Wockhardt announcement​.

However, while the HPRA confirmed the inspection, it told us it had not recommended renewal of the certificate.

A spokeswoman representing the regulator said: “the HPRA can confirm that a GMP inspection was conducted at the Wockhardt Shendra Plant by its inspectors from the February 27 to March 3, 2017. This only covered some non-sterile dosage forms, i.e. injectable dosage forms were not within the scope of the inspection.

The company was advised that corrective actions/preventative actions (CAPAs) are required in relation to the inspection findings.”

She added that: “As is the norm for the inspection process, a decision regarding renewal of the GMP certificate, only for those non-sterile dosage forms, will be taken following receipt and review of the CAPAs proposed in order to address the inspection findings​.”

Wockhardt did not respond to a request for more information.

Update

The spokeswoman representing the HPRA told us “The HPRA has yet to make a recommendation on the renewal​.”

Related topics: Regulatory & Safety, Regulations, QA/QC

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