"This is a common failing of mankind, never to anticipate a storm when the sea is calm" (Macchiavelli when advising Lorenzo de Medici to anticipate change)
Or, in nowadays language: "failing to plan is planning to fail".
Activities for consequent GMP compliance can grow to considerable efforts.
Our experiences told us that usually there are three reasons for problems coming up (in this order):
- too less knowledge of relevant guidelines in detail
- none or wrong priority to transfer regulatory requirements into practice
- no capacity and thus no focussed ressource uitilisation
This is amazing since relevant GMP guidelines (also in Europe) have been in force for many years already.
Actual level of compliance is obviously also dependent on level of inner personal opinion about GMP. If and when GMP is perceived as mere nuisance by the authorities, we should try to re-adjust this positioning.
PharmDev is ready to support you with numerous offerings to bring your level of GMP compliance on a rational ground: "as much as necessary and not as much as possible"