Regulatory Open Forum

Hi Forum,

Can the first commercial production batch after an annual reportable change is implemented that is put on long term stability to support that change (e.g. as recommended in the SUPAC guidance) also be designated a 3.2.P.8.2 "annual commitment" batch?

Even if it is designated a PPQ batch, it is still also a commercial saleable batch, so I don't see why it couldn't also fulfill the requirement to put up a certain number of batches yearly on long term stability (the annual commitment batches).

To your knowledge and in your experience is this acceptable and is this done in practice?

Thank you in advance for your input.

Yes. This is acceptable. 

Hi Forum,

Can the first commercial production batch after an annual reportable change is implemented that is put on long term stability to support that change (e.g. as recommended in the SUPAC guidance) also be designated a 3.2.P.8.2 "annual commitment" batch?

Even if it is designated a PPQ batch, it is still also a commercial saleable batch, so I don't see why it couldn't also fulfill the requirement to put up a certain number of batches yearly on long term stability (the annual commitment batches).

To your knowledge and in your experience is this acceptable and is this done in practice?

Thank you in advance for your input.

Yes, it is common for 1 batch to serve multiple purposes

Yes. This is acceptable. 

Hi Forum,

Can the first commercial production batch after an annual reportable change is implemented that is put on long term stability to support that change (e.g. as recommended in the SUPAC guidance) also be designated a 3.2.P.8.2 "annual commitment" batch?

Even if it is designated a PPQ batch, it is still also a commercial saleable batch, so I don't see why it couldn't also fulfill the requirement to put up a certain number of batches yearly on long term stability (the annual commitment batches).

To your knowledge and in your experience is this acceptable and is this done in practice?

Thank you in advance for your input.

Hi Forum,

Can the first commercial production batch after an annual reportable change is implemented that is put on long term stability to support that change (e.g. as recommended in the SUPAC guidance) also be designated a 3.2.P.8.2 "annual commitment" batch?

Even if it is designated a PPQ batch, it is still also a commercial saleable batch, so I don't see why it couldn't also fulfill the requirement to put up a certain number of batches yearly on long term stability (the annual commitment batches).

To your knowledge and in your experience is this acceptable and is this done in practice?

Thank you in advance for your input.

Isn't your Annual reportable change commitment batch different from non AR change commitment batch? Did you inform the FDA about how you wished to combine both commitments in your AR reportable change notification??? You should be transparent and at least you should indicate this at minimum via CBE-0 instead of asking this on a RA forum!!

Hi Forum,

Can the first commercial production batch after an annual reportable change is implemented that is put on long term stability to support that change (e.g. as recommended in the SUPAC guidance) also be designated a 3.2.P.8.2 "annual commitment" batch?

Even if it is designated a PPQ batch, it is still also a commercial saleable batch, so I don't see why it couldn't also fulfill the requirement to put up a certain number of batches yearly on long term stability (the annual commitment batches).

To your knowledge and in your experience is this acceptable and is this done in practice?

Thank you in advance for your input.