content uniformity characteristic calculation

[Former Member]

Hello !

I'm in a Pharma Industry Project, and is mandatory to use the "Content Uniformity" Characteristic (is a 905 UPS standard) . The formula to calculate it  is very complex because depends of to many values and limits consider others characteristics values . Anybody have been developed this formula or SAP has a standar Function Module ?

Thanks for your comments ,

Regards

Vero

[former_member42743 · Accepted solution]

Also, in config you can create you own formula parameters. i.e. instead of CO0010 you can create a formula function Z1.  Z1 is simply a function module that performs some specific function.  I.e. CO returns the mean of the specificed characteristic.

A Z1 parameter would receive in the value for characteristic 0010 and then return to the formula what ever value you determine in the FM.  If you have the entire thing done in the FM your formula might just be Z10010.

FF

[Former Member]

Content Uniformity calculation:

1^st MIC- ASSAY – Lower/Upper Limit indictors, Sampling Procedure indicator, Single result recording indicator, required characteristic, scope not fixed, RR change document, record measured values, No formula.

Use sampling procedure with fixed sample-10 (if you want result recording for 10 individual assays)

2^nd MIC – Assay Minimum- Use calculated formula- select C9 then use characteristic number of 1^st MIC (e.g.- C910 if first MIC number is 0010)

3^rd MIC- Assay Maximum- Use calculated formula- select CA then use characteristic number of 1^st MIC (e.g.- CA10 if first MIC number is 0010)

4^th MIC- Std. Deviation- You have to input this value. (User can get this value from transaction QGP1 after completing RR for first characteristic- to get this value execute QGP1 with appropriate MIC selectionàselect appropriate inspection lot and click on “Histogram-single values”àA graph will be displayedàIn that graph,  select-Display statistical values. Here you will get standard deviation)

5^th MIC- % RSD- Use calculated formula- (Mean from 1^st MIC * STD.DEV)/100

6^th MIC- Content Uniformity- Here you have to put 3 different formulas

   1^st – If Mean assay is between 98.5 to 101.5 different calculation

   2^nd – If Mean Assay is less than 98.5 then different calculation

   3^rd – If Mean assay is greater than 101.5 then different calculation

Hope this will work or you.

[Former Member]

Hello Vivek, thank you a lot. Your answer is so helpfull.

Regards

Vero

[anand_rao3]

Hi Vero,

You may also explore calulated characteristic indicator. Upon selecting of which, you need to specify the formula where you can co-relate dependency with other characteristics. If you can press F1 at this in indicator the required help would be displayed.

Regards,

Anand Rao

[Former Member]

You can explore "Input processing Control Indicator ".You can design it as per your requirement.