Holding time stability study of intermediates of drug substances


Involved In Discussions
Is there any guideline reference for conducting the holding time stability study of an intermediates of drug substances.

What are all the things to be covered in the SOP / Protocol?



Trusted Information Resource
Drug Substance Chemistry, Manufacturing, and Controls Information

...• Holding times and storage conditions during manufacture...
...Stability data to support holding times for intermediates or during processing should also be provided in this section when warranted (e.g. certain proteins).....

ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

14. Making sure that there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates where appropriate; and

scope of sop/protocol is expected(required) to be similar to that of one used for final api; just that the justification for the specification limits might be expected to be supported by the use-case studies with the different levels of the quality attributes of intermediate.


Trusted Information Resource
though not from the APIS, here's reference from ...


Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients

F. Time Limits on Production of APIs and Intermediates
When appropriate, time limits for the completion of manufacturing steps should be established to ensure the quality of APIs and intermediates. Deviations from established time limits should not compromise the quality or purity of the API or intermediate. Such deviations should be documented and explained. Written procedures should be established for intermediates that are stored before further processing. Where necessary, these procedures should specify appropriate storage conditions, packaging materials, temperature, time, and protection from humidity and light when these are critical for maintaining the quality of the intermediate.
Top Bottom