Takeda says it will help Nihon Pharmaceuticals bring manufacturing operations up to code after Japanese regulators order the CMO to halt production and recall one lot of its vitamin B1 shot.
Nihon' Osaka facility, where the Alinamin-F5 injections were being produced, was shut down until Feb. 25 by the Osaka Prefectural Government after the injections were mislabeled and found to be samples for testing purposes.
Mihoko Ikeda, a spokesman for Takeda, told Outsourcing-Pharma.com that the company has taken preventive measures to ensure that Nihon understands the scope the companies' relationship. For example, Ikeda said the company will:
- Refine the SOPs (standard operating procedures) about how to create and control samples of product;
- Clarify the operating procedures used when employees manufacture products such as testing samples;
- Familiarize employees with the emergency procedures; and
- Reinforce the management system toward all CMOs to initiate more appropriate risk assessment and provide guidance on the basis of potential risks that each company has, and how to reduce such risks.
“Takeda will work to more appropriately manage and oversee all CMOs so that we can prevent the recurrence of a similar incident,” Ikeda said.
But the initiative taken by Takeda to firm up its relationship with Nihon may point to how the company plans to deal with similar issues with CMOs in the future. The recall also is not the first time the company has had an issue with one of its Japanese CMOs.
In 2008, Takeda filed a $26.7m lawsuit against another one of its CMOs, Taiyo Pharmaceuticals, after it had to recall all lots of an injectable antibiotic. Pieces of glass were found in two vials of the Pansporin injectable.
The ampoules in the recalled lot produced by Nihon, which were pulled from one medical institution on Jan. 31, were found to contain methionine and glucose.
Takeda has since verified that only one box of the injections was shipped to a medical institution in Japan and there have been no reports of injury due to the administration of the ampoules.
The Osaka Prefectural Government issued the order for corrective action to Takeda since it is the marketing authorization holder for the injection, and it noted Takeda’s failure to provide appropriate instructions to Nihon related to manufacturing and quality control. In response, Takeda says it will promptly submit a report for corrective action to the government.