Learnaboutgmp Community

Hold Time Study

Dear All,
Please suggest me the guideline for the protocol preparations of the Hold Time Study of Raw Materials, Granules, Compressed Tablets, Coated Tablets.

I will be greatful if any readymade literature is available on the web.

Regards,
H G D

If you are shipping in bulk format, your coated (and possibly compressed) tablets could be covered by a stability program. I carry out hold time studies on intermediates based on physical quality testing and ensuring no degradation on the quality of the intermediates over time. Additional testing based on your products should be considered if you have specific concerns about holding intermediates over a period of time (light degradation, hygroscopic intermiedaies etc etc)