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ISO13485 - The correct standard for pharmaceutical packaging?

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Greig, Jul 3, 2018.

  1. Greig

    Greig New Member

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    Hi,
    Some advice please.
    My company is currently accredited to ISO9001:2015 and we want to 'up our game' as far as demonstrating that we are taking the quality of our products seriously.
    We manufacture polythene bags which ultimately contain pharmaceutical products and I was wondering if moving up to ISO13485 was a relevant move?

    Thanks in advance
     
  2. yodon

    yodon Active Member

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    I'm not advocating one way or the other but just adopting a new standard won't improve quality. Doing so may lighten the burden for qualification and approval by your customers so there may well be a benefit. Just curious where you believe this would effect (quality) improvements?

    As you may know, 13485 did not adopt the Annex SL structure so changing may actually be something of a step backwards (which is, of course, debatable but noted here to ensure you recognize the differences).
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Firstly, welcome. Secondly, you are NOT accredited, but you are certified. Thirdly, unless you only do packaging for pharma clients, you might have to consider the following:

    a) are you being asked to do 13485?
    b) do you have client who only require ISO 9001?
    c) do you want/need to maintain 2 certificates (for each)
    d) do you know it's more than double the cost?
    e) do you know that by the time you have taken exception to the non-applicable 13485 sections, it looks pretty much like ISO 9001?
     
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  4. Vintage Goose

    Vintage Goose Active Member

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    Hi, As Andy says, ISO9001 is a good start. For pharmaceutical packaging, I would suggest looking at either ISO15378 or PS9000 (Pharmaceutical packaging materials for medicinal products)

    ISO15378 is heavily based on ISO13485 and tends to be more aimed at "combination devices" (eg inhalers, syringes, etc), and can be obtained from your usual standards provided, at a cost.

    PS9000 is based on ISO9001 heavily focusses primary packaging (cartons, leaflets, foils, etc). It is available from https://www.pqg.org and is free to download.

    Finding a body who will certify to either can be difficult. In UK some NB will include them within the scope of your 9001 certification. In Europe, other NBs will certify to ISO15378. It depends where you are and what you need. Simply using one of these as guidance for enhancing your quality will be a good start before you thinking of certification.

    Finally I would talk to your key customers and see what they advise, some may have a preference for one over the other.

    Chris
     
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  5. Greig

    Greig New Member

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    Hi Andy
    Hi Andy,
    Many thanks for the welcome and the clarification. The main reason for my question was that I wasn't sure whether ISO13485 was the way to go as it didn't seem to offer much more than ISO9001:2015 and didn't seem packaging specific.

    To take your points as they come:

    1. No, we are not being asked but are currently looking to increase our market presence and wanted to include a more rigorous standard as part of our marketing plan
    2. Our present clients are not asking for anything more than ISO9001
    3. If it is an investment and can generate additional sales then yes
    4. Yes
    5. Yes
     
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  6. Greig

    Greig New Member

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    Hi VG,
    Thank you for taking the time to reply and offer alternatives. I will contact my clients and seek their opinion. I will also download PS9000 and pick the relevant clauses form that as a way forward short term.
     
  7. Operon_Strategist

    Operon_Strategist New Member

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    Hello,

    ISO 15378 is the is quality assurance for primary packaging materials for medicinal products particular requirements for the application of ISO 9001:2008, with reference to GMP.

    Benefits of ISO 15378
    • ISO 15378 has strategic tools that reduce costs by minimizing waste and manufacturing errors and increasing productivity.
    • It helps companies to access new markets and facilitate free and fair global trade.
    • The manufacturer can boost their efficiency of production processes by adhering GMP principles as per this standard.
    • To mitigate your risks especially related to product contamination, mix-ups and errors and ensure product efficacy and shelf life.
    • Assurance of quality products to your clients. Enhance customer satisfaction.
    • Competitive Advantage over other non-certified suppliers.
    • Application of risk management helps to reduce errors associated with the product.
     
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  8. Greig

    Greig New Member

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    Hi, Thanks for the very comprehensive answer. Following an earlier post I have looked into ISO15378 and that is the route we have chosen to go down. I am still waiting for feedback from a number of notified bodies reference certification, which is becoming a concern!
     

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