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?
- Consider using a copy of the EU Guidance for Good Distribution Practice for medicines for human use, 2013/C 343/01 as a guide, as it is against these regulations that the MHRA (or other competent authority) will check your compliance.
- Go through each of the chapters and check your compliance… although the difficulty is that the guidance often states what you need to do/provide, but not the actual processes involved.
- Cross check a selection of goods in and out records to ensure that your products are traceable.
- Review drug recalls, and dummy recall.
- Check that SOPs are up to date, correctly version controlled and signed and dated by the RP and whichever staff were trained on them.
- Review training records.
- Ensure that complaints and deviations were investigated, documented and where appropriate CAPAs were raised, AND closed out.
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!