The MHRA regularly find that self inspections, which are required for GDP compliance, are either not carried out or are insufficient in their scope.
The new regulations advise that third party inspections could be considered helpful, but cannot replace self inspection protocols.
It is also agreed that the self inspection does not need to be carried out by the Responsible Person necessarily, and that a suitable alternate member of staff may audit in their stead. Which team member this may be is entirely up the the RP, however some audit training would be beneficial.
This does not change that the RP may delegate duties, but not responsibilities.
So what are some of the things you should be looking for, and what is the difference with a GDP self inspection and a GDP management review?
GDP management review has more of a commercial focus, and includes reviews of key performance indicators, business goals, complaints and deviations whereas a GDP Self inspection should be based on your GDP activities, including outsourced work, reviewing your facilities, operations, processes and overall compliances with 2013/C 343/01 etc.
Where might a good place to start be?
If you haven’t had an inspection before it can be quite daunting, but if you are compliant and running a well controlled business you have little to worry about.
Take short cuts, skip important details, don’t understand the regulations or just plain don’t care? You should be worrying.
• Are your self inspections up to scratch?
• Is their scope broad enough?
• Are you aware of what the MHRA Inspectors are looking for?
• Are you compliant with GDP?
If not it may be time to get some professional help.
Contact us for a no obligation chat, our Contract Deputy RP service may be of value and remove or relieve some of the stresses of Good Distribution Practice.
Welcome to a new paradigm!
13 Mar 2017
24 Feb 2017