Agila Specialities, being an injectible manufacturer needs to perform all drug manufacturing processes under a sterile environment to avoid any contamination. The USFDA's warning letter notes that an unsatisfactory resolution of the issues may lead to an import ban on products from this facility, reports CNBC TV18's Archana Shukla.
The warning note has been issued to Agila Specilaities after an inspection was conducted by USFDA in June 2013 that found violations to cGMP norms. Agila Specilaities, a unit of Strides Arcolab , is now being acquired by US-based Mylan Inc for a whopping USD1.8 billion. Mylan had recently received government nod for this deal and it is in final stages.
The warning letter says the company failed to even establish procedures to prevent microbial contamination of sterile drug prods. Also, failed to include validation of all aseptic and sterilisation processes in the injectible manufacturing unit.
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During the inspections, visible holes and flaking were observed in gloves claimed to be sterile. And batches of injectable drug products were manufactured using these defective glove lots.
Citing it as a grave concern, the USFDA notes that these defective gloves were even used to perform manipulations directly over empty vials, increasing the chances of contamination of the sterile drug products.
While the company had responded to the observations, the US drug regulator says it disagrees with the company's written response that minimizes importance of glove integrity.
The regulator also noted that significant number of gloves already released by the Quality Assurance team of Agila, or those that were used in production were defective. Also pointing out that the vendor qualification program & incoming material release systems at Agila are deficient.
Industry experts say the violations listed in the warning letter are pretty serious and would take a concerted effort by the company to re-establish quality compliance.
The company has now changed its vendor as a remediation measure. However, since the earlier vendor supplied to all sites, the regulator has raised concerns that there could be a possibility of defectives gloves being used in the other sites.
Strides Arcolab had informed stock exchanges about the USFDA warning letter on Spetember 16th. The company had clarified that subsequent USFDA inspections in other Bangalore facility of Agila has not attracted any observations.
Analysts had raised concerns that the recent regulatory issues at Agila could put the Mylan deal at risk. However, in a statement last week, Mylan clarified that this will not affect the deal.
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