PharmDev Innovations

Trouble shooting

It turned out in nearly all cases we know that "trouble" is regularly caused by insufficient knowledge and subsequently insufficient application of regulatory requirements.

A remedy to this dilemma is then to be provided immediately as "trouble shooting".

Quite often it is massive GMP violations to tackle with, which may jeopardize extension or issuing of a manufacturing authorisation and thus can threw a manufacturer into existential problems.

In such cases we are acting as external "trouble-shooters" based on our long lasting experience and knowledge of regulatory requirements. We keep an unemotional perspective on the "deficiencies", name and prioritize actions and help you with getting ready.

An example from our business:

We got a phone call from a client (having just finished an GMP inspection with unfavourable results) in the morning, were on site at 9 p.m. and investigated and assessed the actual situation during night until 1 a.m. following a fast track.

Next day we presented proposals for action and application could start immediately.

Ten days later we completed a structured and prioritised action plan (CAPA plan) with realistic deadlines for completion, which was taken as the base for the response letter to the authorities.

Result: Manufacturing authorisation was extended under provisions and the needed GMP certificate was issued in time.

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