Concerns over data manipulation lands Chinese API maker with US FDA Warning

By Dan Stanton

- Last updated on GMT

Yunnan Hande Bio-Tech makes the API for cancer-drug paclitaxel, derived from the bark of yew trees
Yunnan Hande Bio-Tech makes the API for cancer-drug paclitaxel, derived from the bark of yew trees

Related tags Food and drug administration

The US FDA has hit cancer-drug API maker Yunnan Hande Bio-Tech with a warning letter citing concerns over potential manipulation of quality test data at a plant in China.

The plant in Kunming, Yunnan Province was inspected in April last year by the US Food and Drug Administration (FDA) and a warning letter​ identifying deviations from current good manufacturing practice (CGMP) was sent to the company earlier this month.

“You lacked controls to prevent the unauthorized manipulation of your laboratory's electronic raw data. Specifically, your infrared (IR) spectrometer did not have access controls to prevent deletion or alteration of raw data,”​ the agency said.

During the inspection the FDA noted a Hande Bio-Tech employee failed to perform the IR identity test for lots of a specific API as part of the quality control release.

“Instead, the analyst at your firm altered the file name in the spectrophotometer containing the sample identification information… tested on April 2, 2014, to support the release of two previously manufactured lots.”

The inspectors also noted the firm’s quality unit’s failure to exercise its responsibility to ensure the APIs are in compliance with CGMP, and meet established specifications for quality and purity.

The letter is the second the facility has received in recent years, with the FDA hitting the firm with a warning​ in 2010 after complaints surrounding certain API batches were not investigated properly.

Yunnan Hande Bio-Tech manufactures the ingredients for the drugs paclitaxel and cephalomannine, both of which are major taxanes produced by yew trees and used to treat a number of types of cancer including ovarian, breast, lung and pancreatic cancer.

The company did not respond to requests for more information when contacted by this publication.

Related news

Show more

Related products

show more

Increasing the Bioavailability of Oncology Drugs

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Efficient Freezing & Storage of Biopharmaceuticals

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Manufacturing Drugs with Highly Potent APIs

Manufacturing Drugs with Highly Potent APIs

Content provided by Altasciences | 28-Sep-2023 | White Paper

In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs),...