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  1. #1
    Validation Expert
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    Default Variation of secondary packing material in stability samples and commercial packing

    Dear forum Experts,

    We are manufacturing APIs and these are usually packed in HDPE bags by placed white following black food gradeLDPE bags. But some of customers are insisting me to send the material on fiber and Aluminium containers. But we have packed stability samples and retention samples in HDPE containers.
    Now my questions are,
    1. Do we have to initiate the stability studies by packing the samples in fiber and Aluminium Containers?
    2. Our stability data what we have as on now i.e stability samples packed in HDPE containers, can be suitable?
    3. We are going to submit the DMF for that product. What necessary actions to be taken to avoid these situations in future.

    Kindly help me at earliest to overcome above situations.

    Thanking you

    Pulla Reddy Karnati.
    Last edited by Pulla Reddy; 04-12-2012 at 08:01 AM.

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    Last edited by Pulla Reddy; 04-12-2012 at 08:01 AM.
     

  3. #2
    Validation Analyst
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    Default

    Sounds like you already have stability data on API stored in contact with HDPE.

    So if the product in the fiber and aluminum container is in an HDPE bag inside that container, you'd most likely be fine. But if the API contacts fiber or aluminum, then no. That's the way I understand these things.

  4. #3
    Validation Expert
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    Dear KM-USA,

    Our API does not contact directly HDPE or fiber/Aluminium containers. Material packed in double lines food Grade LDPE bags then placed in HDPE container and also we have a same stability data for 3 years and it is going on.
    But Some of customers are insisting to send the material packed in double lined food grade LDPE bags then placed in Fiber & aluminium containers.
    But as on now we did not perform the stability by pack the samples in food grade LDPE bags then further kept in fiber/Aluminium containers.

    Can we dispatch the material with existed stability data? Is there any justification to avoid further queries? How we can justify that the product quality will not effect in the variation of secondary packing?

    Kindly supply your valuable answer.

    Thanking you

    Pulla Reddy Karnati
    Last edited by Pulla Reddy; 04-18-2012 at 04:34 AM.

  5. #4
    Validation Guru
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    Default

    If you are customers are insisting you to send material in a specific container there might be a reason. You need to ask customers what are their concerns.
    If your customers are over seas probably their regulators will not accept the secondary packing materials you normally use and also there might be some shipping concerns during handling and also stability when they traverse various climatic zones.

    You need to ask your customers and make a list of thier concerns and reply.
    Durga Prasad

  6. #5
    Validation Expert
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    Apr 2012
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    Hi,

    First if all secondary packaging is not related to the drug stability. It only provides protection from mechanical shocks during the Transport of the materials. Until and unless there is not change in the primary packaging materials[material that contact the drug substance], you are not required to worry about it.

    Then, if the customer is going for ANDA submission, then discuss with the customer about this solve your problem.

    Srikanth N
    http://stabilitystudies.blogspot.com

  7. #6
    Validation Analyst
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    [QUOTE=Pulla Reddy;19020]Dear KM-USA,

    Our API does not contact directly HDPE or fiber/Aluminium containers. Material packed in double lines food Grade LDPE bags then placed in HDPE container and also we have a same stability data for 3 years and it is going on.
    But Some of customers are insisting to send the material packed in double lined food grade LDPE bags then placed in Fiber & aluminium containers.
    But as on now we did not perform the stability by pack the samples in food grade LDPE bags then further kept in fiber/Aluminium containers.

    Can we dispatch the material with existed stability data? Is there any justification to avoid further queries? How we can justify that the product quality will not effect in the variation of secondary packing?

    hi,

    IF you keep existing pack (HDPE bag with double lined food grade LDPE bags) in aluminium/fiber containers, it should solve your issue as well as customer requirement. in that case aluminium/fiber containers does not have any quality impact on API.

  8. #7
    Validation Guru
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    Dear Mr. Pulla Reddy,

    Stability studies conducted for any material along with packing.

    We need to consider the material stability in the packing.

    No seperate study for packing is required. You can submit the data you have to the regulatory authorities.

    No Objection you get, I hope.

    Regards,
    Bujji Reddy Kanchi
    8008889185.

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