CP Pharma gets FDA warning for Wrexham facility
pharmafile | November 18, 2010 | News story | Manufacturing and Production | CP Pharmaceuticals, FDA, FDA warning letter, Wockhardt, manufacturing compliance, pharma manufacturing
UK drugmaker CP Pharmaceuticals is the latest to receive a warning letter from the FDA for failing to meet standards at a manufacturing facility.
Problems at the company’s plant in Wrexham were uncovered during a July inspection by the US regulator and included several issues that could lead to compromised sterility of pharmaceutical products.
The Wrexham facility is the main manufacturing site for the UK operation and produces generic hospital pharmaceuticals such as injectable cancer drugs, anticoagulants, anti-infectives and pain management products, as well as oral dosage forms for retail pharmacies, in addition to offering contract manufacturing services.
Among the issues uncovered and described in the FDA warning letter is the lack of separate areas or other control systems to prevent contamination during aseptic processing, mould growing on the wall of a class 100 production suite and inadequate aseptic technique by workers.
CP Pharma had no documented evidence to show that it had checked airflow patterns in the aseptic production suites. These are typically carried out using smoke studies and are used to detect and prevent turbulence, which can act as a channel for air contamination, and stagnant air.
Other citations include a failure to investigate batch failures properly, and a lack of validation data for various laboratory methods used in quality control.
The agency also says there are additional concerns regarding the quality of sterile drug products made at the facility, including a failure to recognise that the production environment was not under control. Given the presence of mould in the production areas CP Pharma should also have implemented routine cleaning with a spore-killing agent, it notes.
CP Pharma is an operating unit of Wockhardt UK, which is in turn part of India’s Wockhardt group. The company filed two responses to the FDA in September but these were too late to be considered ahead of the warning letter being issued.
Phil Taylor
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