CP Pharmaceuticals Limited – one of the Step-down subsidiaries of Wockhardt based at Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, Wales, UK which reported a PAT of Rs. 179.08 crore for the year ended March, 2016. (turnover amounted to Rs. 553.52 crore) has been slapped with a warning letter from the US FDA in relation to the significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. This comes after the company responded to the inspection results on November 3, 2015 followed by a couple of more updates.
The principal activity of the subsidiary is Manufacturing and Sale of Pharmaceuticals as well as research and manufacturing activity on customer products & manufacturing technologies.
Wockhardt said in a press release to the Bombay Stock Exchange that the mentioned subsidiary does not have any business in the United States (USFDA is the regulatory authority of United States) and that the CP Pharmaceuticals has already initiated the required steps.
The U.S. Food and Drug Administration (FDA) inspected the drug manufacturing facility, from 5-9 October, 2015 and again from 12-13 October, 2015.
Here are the summary of the violations observed by the US FDA Inspectors:
Failure to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile
Failure to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas. (this is a repeated observation from the previous warning letter (dated October 29, 2010).
While there were just 2 detailed observations made, the firm’s response to these observations were poorly drafted from a CGMP Compliance perspective.
Although the company included a revised procedure on quality oversight of operations, it did not retrospectively evaluate video footage to identify poor aseptic practices and identify any batches produced under these conditions.
While the company mentioned that it will monitor all personnel conducting aseptic activities it failed to describe any details of how this assessment will be conducted.
The FDA has now asked the company to provide a copy of the current risk assessment and all the actions to be taken as a result of this risk assessment to be performed by the company.
A comprehensive evaluation of the design, control, maintenance, and oversight of the aseptic processing lines
A risk assessment of the potential effects of the observed deficiencies on the quality of the drug products and as well describe how these deficiencies may have impacted the quality of drug products released for distribution.
An overall management strategy that describes how the executive management will oversee improvements in operations and ensure ongoing oversight to provide for sustainable quality assurance.
Failure to correct these violations may result in FDA refusing admission of articles manufactured at CP Pharmaceuticals, Ash Road North, Wrexham Industrial Estate, Wrexham, United Kingdom, into the United States.