A discovery was made in late 2015, and now recently reported, concerning a Japanese company called the Chemo-Sero-Therapeutic Research Institute (Kaketsuken), based in Kumamoto. The company is a manufacturer of blood (plasma) products and vaccines. The product portfolio includes factor VIII, a drug product used for the treatment of the bleeding disorder haemophilia.
Investigators discovered the company had been adding unauthorized ingredients to its products and allegedly falsifying data in order to hide this fact. Worryingly, an investigative panel discovered that the institute had been doing so for more than 40 years.
The main charges are:
Kaketsuken has been producing blood products using improper production processes.
The company began falsifying production records for national inspections around 1995.
To add to this, Pharmaceutical Manufacturing reports “According to allegations, the company went as far as to artificially age fake documents exposing them to ultraviolet radiation in order to produce the needed historical paper trail.”
Following the discovery, Japan’s Ministry of Health Labour and Welfare (MHLW) issued a demand to all manufacturers of biological products within its territory, requiring each company to confirm that the current actual manufacturing process complies with the approved regulatory files held within Japan.
This requirement means all manufacturers of drug products, active pharmaceutical ingredients, and intermediates, must review all of their manufacturing batch records and interview their operators to confirm conformance. This needs to be carried out by an independent quality department within each company. The due date for domestically owned companies is by the end of February, with foreign owned firms needing to complete the activity by March 22, 2016.
The issue highlights the importance of data integrity in the pharmaceutical sector. Digital Journal recently reported on a different type of data integrity violation, relating to an Indian pharmaceutical company called Ipca Laboratories. The charges here related to the accuracy of laboratory records.
