I want to share the article originally written in Japanese. It is from “nikkan yakugyo” and includes responses from the industry. The rough summary I wrote in English is as follows;
Carcinogen self-inspection, issues related to costs and deadlines, and various responses depending on the size of the company and the number of items.
Since it is an international trend, it is understandable that “call for review in Japan” is necessary, but responses are different among the group of JPMA, GE Pharmaceutical Manufacturers Association, and OTC Pharmaceutical Manufacturers Association. And responses are also different depending on the size of the company and the number of items.
For companies that do business globally and have experience in the risk assessment of nitrosamine, the content of the self-inspection is within the expected range.
On the other hand, it will be a heavy burden for generic companies, especially with a large number of items, after dealing with the assessment under ICH Q3D.
It requires performing the risk assessment on all possible substances such as APIs, excipients, reagents, packaging materials and containers, and printing inks. Considering works to send and collect questionnaires to all those suppliers, the one-and-a-half-year deadline of step1 is considered strict.
Since the number of outsourced test facilities that have equipment with high sensitivity and meet GMP standards is not so many, there is a concern that the test will not proceed as expected by the concentration of requests.
There is a concern that re-evaluation will be necessary due to new findings regarding nitrosamine contamination.
In conclusion, early Q & A issuance and establishment of a system for consultation are now strongly desired.
I hope it will help you understand situations in Japan.
Dear Japan colleagues… my colleague @ShinKim from USP’s APAC team is working with some local partners to develop a Nitrosamine Training/Workshop. Potential collaboration? Thanks in advance for all your support.
It is pleasure to speak with you Yosukemino-san.
I am Shin, customer engagement manager responsible for managing Japan & S. Korea.
I personally look forward to working with you and will keep you posted on the Nitrosamine education course once it is organized and ready to be hosted.
Due to yearly NHI price revision, in generic manufacturers with lots of products in Japan, we don’t have many resources to control nitrosamines in each product. This is a problem from a different perspective.
We must cooperate and share nitrosamines information because we don’t have enough information and expertise to perform a risk assessment and control nitrosamines.
@Yosukemino great agenda for the workshop. Please let us know if there is an opportunity for any member of the community to participate or contribute. Also, let me know if you need additional resources about Nitrosamine Exchange.