stability study

[Former Member]

Hi experts,

Why is BOM assignment needed in stability study.what is the usage of BOM here.Is scheduling essential in stab study or optional.

regards,

Shanmugam

[Former Member · Accepted solution]

Dear Shanmugam,

Scheduling is mandatory.

BOM assignment is not necessary, the purpose to assign the BOM is,,

In a stability bill-of-material (BOM), you document the components, substances, or ingredients that make up the material or product to be tested, from a stability or shelf-life perspective. In a stability study for a self-produced drug, for example, the laboratory is usually more interested in the proportion of active ingredients and chemical composition of the compound, rather than the material BOM associated the process order or production order. The stability BOM is used for documentation purposes only. In a BOM, you can also describe the compound or product using text components, which can be especially important for newly developed products.

Regards,

Shyamal

[Former Member]

Hi,

In a BOM, you can also describe the compound or product using text components, which can be especially important for newly developed products.

How to describe the components using texts. Do you mean some sort of long texts usage in BOM.

regards,

Shanmugam

[Former Member]

Dear Shanmugam,

Sorry for late reply,

Actually you are correct, it can be define by some sorts of functionality,

e.g.:- In Bom you can add them as Text by selecting the Item Category as "T" - Text.

Regards,

Shyamal

[Former Member]

Hi Thanks,

Shyamal I could not fully understand what you meant.Are we adding some sort of document in QST01 -Stab study.Will you explain little simpler the need for BOM.

regards,

Shanmugam

[Former Member]

Hi,

I do not think BOM assignement is necessary in stab study ,but Scheduling is necessary to schedule your lots for stability inspection as per your package assign .

Regards

SANIL