Hi,

I would like to pose the following questions to the group in regards to the annual batch stability program


1)      How many batches are placed on stability for the annual batch program in a given year assuming one formulation in one package presentation.

a.       One batch placed on stability during the year regardless if one(1) batch or 500 batches are manufactured during the year

b.      Based on a production forecast, x% are targeted to be placed on stability during the year (forecast is 500 batches and 1% placed on stability = 5 batches a year placed on stability)

c.       One batch for every x batch manufactured during the year (e.g. every 25 batch is placed on stability)

d.      Seasonal studies (4 batches - one manufactured during winter, spring, summer and fall)

e.      Other


2)      How many batches are placed on stability for the annual batch program in a given year assuming one formulation in multiple package presentations.

a.       One batch placed on stability during the year in each package presentation (number of batches = number package presentations)

b.      Based on a production forecast, x% are targeted to be placed on stability during the year for each package configuration (forecast is 10 batches for package A and 500 for package B and 1% placed on stability = 1 batch in package A and 5 in package B)

c.       One batch for every x batch manufactured/packaged during the year (e.g. every 25 batch is placed on stability for every package configuration)

d.      Seasonal studies (4 batches of every package configuration - one manufactured / packaged during winter, spring, summer and fall)

e.      Other



3)      Are the products you manufacture / package

a.       Registered products  (NDA, ANDA, global, etc.)

b.      Non-registered products (e.g. OTC monograph)




Renee Kolbush
Novartis Consumer Health, Inc.


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