Annual Commercial batch studies required to be in full commercial pack?

[John O’Neill]

#25112

For an industry colleague.
Are annual commercial batches required to be set down for studies in full commercial pack, inserts and all?

[John O’Neill]

#25113

The simplest and safest course of action is to set down the annual studies in full commercial pack, but some companies use the justification based on a statement in the WHO Stability Guidance that infers that commercial packs that don’t influence stability of the product can be omitted. This can save time and resources if you usually pull the samples before they go out for final packaging. Take that course only with the blessing of your QA and Reg affairs folks and better still, include this course of action for annual commercial studies in your registration (along with the WHO justification) to get approval up front and in writing.

What do the rest of our Stability colleagues think?

[Walter Routh]

#25117

In one instance my company received an observation from a South American country because we had not removed the primary container from the secondary cartons. In response, we implemented a statement in protocols (if supported by data) that the secondary carton did not provide any stability protection and were then able to continue keeping material in the cartons for products supported in this way. That only applied that to zone IVb studies since that’s where the observation originated, and no other country had an issue.

Ultimately, for convenience I’d prefer to keep studies in the full packaging to avoid additional handling, but I have often seen the need to conserve chamber space since the cartons involved were very bulky for the small dosage contained within them. I’m talking 5 to 10 large bins of product vs. 1 or 2 bins if taken out of the secondary packaging. We’ve not had an issues from any inspector except that one IVb noted above. Still, a statement in the protocol justifying the removal from the secondary packaging can ensure you don’t get an observation if you do need to place them in the chamber outside of the full commercial configuration.

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