In agreement with this. The ambiguity for GMPs established within a start-up opens itself for improvement and new policies that will, in turn, reduce vagueness. At the start of production, this helps as you can keep production going forward. In this sense it is a positive for GMPs to be ambiguous.
The negative aspect of having ambiguous GMPs is that it allows varying interpretations from person to person. This could have a negative impact on production as one person can read and follow a process and the next person can read and follow a process incorrectly just because that was how he/she understood it.
For a start-up that is looking to address these type of issues, hiring an experienced QA consultant, employee, or team can help mitigate these issues in a timely matter and bring a much better understanding on how processes should be run and how documents should be interpreted.
From my experience, GMP (good manufacturing practices) quality system documents are general but clear. As a new employee, the company trains you on the GMP regulations that the company upholds. If there are discrepancies, then many of the other employees will educate each other on it. Along with requesting for an updated GMP document. New companies that do not have a GMP quality system document is pretty much setting up the company for failure. The company needs some set regulations documented for employees to adhere to. Or else, documentation will not be consistent or clear. For companies that have GMP quality system documents that are ambiguous can be very detrimental. It shouldn’t be left for interpretation, it should be clear and concise.
It is important that companies, no matter how small, should include GMP’s, Good Manufacturing Practices. With GMP’s, a set outline of regulations or requirements is put in place for the company. If there is a startup company that does not have any GMP’s set yet, that does not necessarily mean that the company will fail. This gives the company the opportunity to create and determine the regulations that they will follow. It would be best if the company establishes the GMP in the beginning, that way as they start creating products, it will be understood as to what to follow. However, if the startup company does not set the GMP’s and delays it, this can hurt their success. It is always better for companies to make sure that GMP’s are in place, that way they will follow specific regulations.
