I always remind my client to abide by Murphy's law. Things can go wrong and it will always go wrong at the wrong time.
Many pharma manufacturers have been caught with this situation but only a few learnt their lesson well.
There are still many manufacturers who choose to give more priority to meeting sales demand rather than keeping an eye on their GMP state of compliance. When we get too comfortable, we tends to overlook the common mistakes and non-compliances, to the extent that it becomes 'normal'.
It will take few rounds of audits by the GMP auditors before the bad state of non-compliance get noticed and warrants a suspension of the manufacturing operation. Only when this occurred, the alarm bell will immediately be sounded in each of the management's head and trigger finger pointings. But alas.... this is too late. Damage is done.!
So, what's left next is 'damage control'. With the operation suspended, the affected manufacturers will now have ample time and space to rectifying all their problems and hopefully get back their manufacturing license within the shortest time possible.
But wouldn't it be good if efforts are taken before the suspension is imposed...??