The Swedish CDMO has received a non-GMP compliance warning following inspection at its site in Lancashire
Swedish CDMO Recipharm has halted production of potent drugs at its site in Lancashire, UK, following a statement of non-GMP compliance issued by the Medicines and Healthcare Products Regulatory Agency. The letter cited potential cross-contamination risks.
"The measures to prevent and detect cross-contamination were deficient and presented a risk that cross contamination between products could occur and would not be detected," reads the Eudra filing.
The scope of statement of non-compliance is limited to the manufacture with associated primary packaging of medicinal products considered to be potent products and that are non-critical to public health.
GMP inspectors visited Recipharm's UK site in August and found that the site operates separate manufacturing areas for products considered potent and non-potent. "In particular, the potential for cross-contamination with highly potent products poses a risk to public health and the National Competent Authority therefore believes that it is necessary in the interests of patient safety to immediately restrict the manufacture of non-critical potent products until the issues are satisfactorily resolved," reads the statement.
The news comes at a time of high demand from customers. In a move to continue serving its clients the CDMO has announced that it will not close its plant in Höganäs, a coastal city in southern Sweden. The site handles sachet and stick pack filling, primarily for powders and granules.
"In 2017, Recipharm announced the intention to discontinue the operations in Höganäs and evaluate different options for the facility, including divestment of the site. During this evaluation, new customers have actively approached Recipharm, adding demand for several new products in Höganäs. Consequently, Recipharm is now reversing the decision to discontinue the operations in order to progress these new opportunities," the company said in a statement.
The decision saves the 45 jobs at the site. “The decision to stay in Höganäs is a consequence of the increased demand for the technology and capacity we can offer. This has been somewhat unexpected, but we are of course pleased to see new customers entering," said Thomas Eldered, Recipharm CEO.
Eldered said the company expects to see volume growth already in 2019. "I am also glad that our highly skilled workforce will have continued employment with Recipharm. They have shown a high level of commitment during this period, he added.
The decision to continue the Höganäs operations will trigger release of the associated accrual for estimated closing costs. This will lead to a minor non-recurring income that will be reported in the Q3 2018 results.