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  • neb2 replied to the topic Discussion Topic: Vagueness of GMP's in the forum Quality Systems Management 7 years, 12 months ago

    GMP’s ambiguity does make it more difficult for startup companies. These companies could have the required description in order to have a compliant quality system but they do not have an pre-existing framework that they could follow. Therefore, creating quality document, SOP’s could be challenging, since the terms used in these documents needs to be properly used, other than that you could have people doing extra and unnecessary work, it could also mess up your system. Nevertheless, they have the chance to mold this GMP and adapt it to to fit to your company business.