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  • sns34 replied to the topic Discussion Topic: Vagueness of GMP's in the forum Quality Systems Management 7 years, 12 months ago

    Yes, I do believe that the GMP’s ambiguity does make it a lot more difficult for startup companies that do not have an existing framework of general requirements to follow. The ambiguity allows for debates to arise and it makes the company question “where do we begin?” Due to the uncertainty, the company would struggle, and ultimately find a way to properly understand regulation, by investing in training and outside firms to make sure everything is in compliance. However, in the long run, it will allow the company to follow their own standard and innovation of product, but it still gives them a framework with requirements on their quality system in order for them to not be out of compliance.