Wockhardt advised to hire consultant for data check
Recently, concerns were raised over manufacturing facility of the Mumbai-based drug company Wockhardt. In the backdrop of these issues, the USFDA has warned the firm about the lack of accurate and reliable data. This is reported as serious violation of good manufacturing practice (GMP) standards and the FDA shows concerns about all data that the firm has generated.
In a recent development, the USFDA has issued a 3000 word letter to Wockhardt. In this, the firm has been asked to hire a third party consultant for the review of data and for addressing the issues that have been notified. The FDA has also asked the firm to enquire its existing and past employees to understand about the reported data. A third party auditor will help in reviewing the data and in detecting issues with data integrity. Thus compliance with GMP can be established.
As notified by the FDA, the firm has been unable to implement a robust quality system. As regards the repeated citations and observations made after inspecting the firm’s manufacturing facilities, it shows that the quality unit is not functioning in the expected way. The responsibilities need to be exercised in a more effective manner.