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Measuring Process Capability in a Product Stability

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  • #38852

    Sandeep gupta
    Member

    Hello All,
    I am woriking on a process improvement project in a pharmaceutical Co. I would like to measure process capability for product evaluation (Stability Study) process. Could you please guide me how to measure process capability of this process and what kind of KPI (s) should I establish to report to our VP on monthly basis.
    I would really appreciate all your guidance.
    Thanks
    PharmBB

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    #117344

    melvin
    Participant

    You need to start with identifying the product metrics that characterise performance – these should be your KPIs – yes?

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    #117346

    Ganapathi
    Participant

    Sandeep,
    Bob is right that you need to define the metrics in order to arrive at the process capability. For yr process some of the characteristics may be:
    1. Purity (or Impurity) level in yr product as compared to target value
    2. Weight (or Volume) of each package as compared to nominal or labelled value
    Apart from these, yr list of  KPIs may include:
    1. Cost per unit weight or unit volume
    2. Total cycle time from ‘Issue’ of raw materials to ‘Dispatch’ of  finished product.
    3.  Product loss ( that includes rejection, waste generation, sampling for analytical test etc) or Yield percentage.
    Good Luck 
    Dr.MG

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    #117362

    Broomfield
    Participant

    Hi Sandeep, normally you should be first define your busines case to established your project goales and after in conjuction with your BB define which KPI´s are very important to your process. To stability studies depend of the product and the pharmaceutical forms, then you should be analyze and report all specifications results and do tracking to each test. However remember that you need obtain at least 50 individual values or 25 subgroup data to calculate the Cp´s.
    Alan
     

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    #117365

    vishwakarma
    Member

    Dear Mr. Ganapathi,
    Thanks for your reply, Just wondering if you have a case study or an article which I can look at.
    Thanks
    Sandeep

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    #117367

    Joseph Banerjee
    Participant

    I completly agree with Alan that first you need to identify the KPI’s for your process .

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    #117480

    Ganapathi
    Participant

    Dear Sandeep,
    I do not have any case study since I’m not in pharma line. However, the following articles published through this site would certainly help:
    https://www.isixsigma.com/ library/ content/ c020925a.asp
     
    https://www.isixsigma.com/ library/ content/ c040412a.asp
     
    https://www.isixsigma.com/ library/ content/ c021021a.asp
    You can also many find articles  and discussions  by “searching” (top right hand side) just by the word “pharma” or “pharmaceutical”.
    Good Luck
    Dr.MG

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    #118693

    k.bhadrayya
    Participant

    Dear Sanddep gupta
    Though it is late, i happend to see all replies sent to you by discussions of participants. If you have already got solution, please ignore it other wise you may look into it.
    You have some value of the quality characteristic Stability agianst which you would like to assess that of your sample. Here you might be having lower and upper specifications.This is what i could understand it.
    For the measure of CPk or CP you need to know the average value and standard deviation. To arrive at these statistics, more no of samples under identical conditions need to to be taken and determine average and standard deviation.Once Cp or Cpk are calculated we can link up with Sigma levels and asses at what levels the process is capable of running defect free production.
    If you are already a Six Sigma expert , there may not be any difficulty. If you are only pharmacy pereson, perihaps I amy try to help yopu. Let us know. I do have some experience in drug industry and also about six sigma methodology. Let us know.
    k.bhadrayya
     
     
     

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