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Scott replied to the topic Discussion Topic: Vagueness of GMP's in the forum Quality Systems Management 7 years, 8 months ago
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.