Thai API Facility Hit With Warning Over Data Integrity
The FDA has warned a French drugmaker for data integrity issues related to the production of active pharmaceutical ingredients at its Thailand manufacturing plant.
According to the Feb. 27 warning letter published Tuesday, Novacyl failed to maintain complete raw data from testing and method validation, undermining its ability to evaluate the quality of its APIs.
During an April 21 through April 25, 2014, inspection, investigators observed a data analyst selectively invalidating data during API testing. During system suitability testing, the analyst also discarded one of six performed injections with no justification, the letter says. The FDA deemed Novacyl’s plan to revise its SOPs to better control raw data inadequate because it doesn’t address data retention and urged the firm to determine the extent of inaccuracies in reported data.
The FDA also dinged the Samutprakam, Thailand, facility for not having a secure computer software system, raising questions about the authenticity and reliability of Novacyl’s data and the quality of its APIs. Novacyl said it would update the system and make it password protected, but the agency said the response lacked details.
The letter references similar data integrity concerns found at the company’s Jiangsu, China, facility, and recommends Novacyl immediately undertake a cGMP evaluation of all of its facilities. The agency also urged the company to conduct a risk assessment of the effect of GMP lapses on API quality.
The warning letter further chides the firm for failing to ensure that reprocessed APIs meet specifications. Investigators observed the firm reprocessing rejected batches of ingredients into other ingredients. The company also reprocessed materials that contained dirt specks, but did not explain why its quality unit failed to provide proper oversight of cleaning operations and contamination problems that led to the dirt, the FDA says.
Novacyl was not available for comment. To read the warning letter, go to www.fdanews.com/03-11-15-Novacyl.pdf. — Kellen Owings