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Hi Rajib- I think you should refer Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance
ICH E6Generally when Temperature excursions occur:
-First quarantine the study product from clinical use and investigate the root cause.
- Always follow available "contingency plan SOP" (company specific)
-Record all the relevant information.
-Notify Investigator, sponsor and CRO
- Assess the details of the temperature excursion and decide if the product is acceptable for use or it should be returned or destroyed.
-Assessment will be based on stability data/ labeling/or information from manufacturer
Apart from RLD Drug label, study protocol usually states the conditions/controls under which the study product should be stored in an effort to preserve the quality, strength, purity and identity of the product. If excursions are permissible, this should be described in the study protocol.
In worst case scenario FDA may point this in 483-Inspection observation(s) that the study drug being stored at temperatures outside of
the protocol/required range.
If you still need more information,
It would be best to ask the FDA review division (project manager) that is overseeing your application.
Original Message:
Sent: 02-Jan-2018 02:09
From: Rajib Kumar Baishnab
Subject: Handling of RLD for Bioequivalance Study
Dear Members,
We are developing a Product for ANDA submission. Accordingly we have purchased the RLD of that product to conduct the Bioequivalence study.
Storage condition of that RLD is given below:
Store at 20- 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F)
During transportation of RLD from point of purchase to manufacturing site ,upper alert limit temperature of Data Logger was set at 30°C and lower alert limit was set at 15°C. But as per data obtained from data logger, we found temperature below lower alert limit (15°C) for 1 hour and also found temperature above upper alert limit (30°C) for around 15 Days .High extreme temperature was found 34.4°C and Low extreme temperature was found 14.5°C & Total Trip length was about 28 Days.
I have gone through the FDA guidance on Handling and Retention of BA and BE Testing Samples but didn't find about anything on excursion of temperature during transportation of RLD.
Please suggest if there is any specific FDA guidance for the RLD transportation on temperature & Humidity requirement. Also please suggest whether FDA will raise any query if we submit the above data as the proof of storage during transportation.
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Thanks & Best regards
Rajib Kumar Baishnab
Manager, Regulatory Affairs
The ACME Laboratories Ltd.
Dhamrai, Dhaka-1350, Bangladesh
Ph: +8801990-407587
Email: rbaishnab.qo@acmeglobal.com
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