Regulatory Open Forum

Hi,

I wanted to clarify the FDA requirement for placing at least 1 lot of drug product on stability each year.

In case we produce multiple strengths (5), do we have to put 1 lot from each strength in stability study every year (5 lots/year) or could we do bracketing and place only lowest and highest dose of drug products (2 lots/year).

Also does this annual requirements starts from the beginning of calendar year or from the date of the approval? ex. we got approval in May. If we place a new lot on stability in January, would it count as meeting the requirement, or only lots produced and placed on stability after May would count for the 1 lot/year requirement?

Thank you

Hi,

I wanted to clarify the FDA requirement for placing at least 1 lot of drug product on stability each year.

In case we produce multiple strengths (5), do we have to put 1 lot from each strength in stability study every year (5 lots/year) or could we do bracketing and place only lowest and highest dose of drug products (2 lots/year).

Also does this annual requirements starts from the beginning of calendar year or from the date of the approval? ex. we got approval in May. If we place a new lot on stability in January, would it count as meeting the requirement, or only lots produced and placed on stability after May would count for the 1 lot/year requirement?

Thank you

Hi,

I wanted to clarify the FDA requirement for placing at least 1 lot of drug product on stability each year.

In case we produce multiple strengths (5), do we have to put 1 lot from each strength in stability study every year (5 lots/year) or could we do bracketing and place only lowest and highest dose of drug products (2 lots/year).

Also does this annual requirements starts from the beginning of calendar year or from the date of the approval? ex. we got approval in May. If we place a new lot on stability in January, would it count as meeting the requirement, or only lots produced and placed on stability after May would count for the 1 lot/year requirement?

Thank you

Hi Valeria,  I agree with the previous responses.  You must follow what is approved in the NDA in a post-approval commitment.  All the companies I've worked with/for do this on a calendar year basis.  As a best-practice, you should place the first batch manufactured each year on stability.  I've known companies who didn't do this only to find out at the end of the year that no batch was placed on stability.  It's not a fun discussion to have.  

Hi,

I wanted to clarify the FDA requirement for placing at least 1 lot of drug product on stability each year.

In case we produce multiple strengths (5), do we have to put 1 lot from each strength in stability study every year (5 lots/year) or could we do bracketing and place only lowest and highest dose of drug products (2 lots/year).

Also does this annual requirements starts from the beginning of calendar year or from the date of the approval? ex. we got approval in May. If we place a new lot on stability in January, would it count as meeting the requirement, or only lots produced and placed on stability after May would count for the 1 lot/year requirement?

Thank you