From experience, I’ve found that GMP creates more arguments than anything else within a company and that is because of the ambiguity. The ambiguity lends itself to debate and people tend to get carried away with minor details. Discussions can carry on for hours as people debate whether a step in the process should be labeled as “may” or “should.” As it was discussed in this week’s lecture, knowing the difference in definitions of words such as “shall” and “should” have a large impact on documentation and most people are not familiar with the minor differences in the wording. Oftentimes, with GMP SOP’s, the people writing them may be the experts on that particular machine or process, such as a machinist or technician but these are not the quality assurance personnel that need to ensure that the correct vocabulary is used. In this case, a quality person would be responsible for learning the machine in the way that a technician would because if they did not, they run the risk of using the incorrect word. If you have a technician who cannot explain a process well or a quality person who is unable to communicate or work well with others, it will create an array of problems.
I think that this ambiguity does make it harder for start up companies to initiate GMP without pre-existing GMP’s because it creates a problem of where to begin. The best approach at that point may be to hire an experienced QA person to lead the job but this can result in that person is limited in resources and money. Additionally, the QA person may only be familiar with GMP standards at their previous job and not with how it should be best run at the new start up.