Indeed the ambiguity of GMP’s pose an issue with start-up companies that do not have a good foundation in a quality system. Ambiguity can be problematic in terms of having departments agree on a solution, the ambiguity can cause internal debate depending how the individual interprets the general requirements. Having the GMP’s vague is to allow each company to generate it’s own framework system to satisfy the GMP requirements, the forces all companies to put resources in generating a unique system. In addition, companies are not limited to creating guidance documents to further assist in understanding the GMP general requirements, in fact FDA and ISO encourages this. My opinion in this is that , if all companies could copy and paste their quality system from one another, the value of GMP in general would be devalued and not much attention would go into it because it would be mainstreamed.