Hear me out on this one …….if you have not met your inspector take time to check him out. Google him and look on the MHRA website to see what he may have presented at a MHRA conference for example. Does he come from an auditing background? Is she a pharmacist ? Did he work in Industry and is he familiar with GMP? Knowing your inspectors background may just help you to consider where he might focus his attention. Some inspectors are fastidious about paperwork and will crawl all over your QMS and your GDP records looking for ” Ditto ” marks and missing parts of ” Dates ” or alterations without both signatures and dates, others have a more pragmatic approach. Some insist on seeing every temperature data log for ambient as well as cold chain and will present you with a ” Major ” for not being able to evidence your ” Ambient supply chain validation” because you do not have enough evidence, missing data or the report of your findings is lacking.
You need to be inspection ready every day not just on inspection day. Read the new GDP guidelines(2013/c 68/01) , know them inside out and it you are not sure how to interpret them and if you are compliant check it out now! If you get notified of an inspection do you homework and check your inspector out ! It may just help you on the day. There is too much to do to remain compliant now to leave it to the ten days from notification of your inspection to the actual day of the inspection. Read your QMS as soon as you can and be honest with yourself is it fit for purpose, and if not why not?