Self-Inspections are an important part of GDP and ensuring you keep your activities and licence compliant.
Self-Inspections are designed to highlight any non-conformities and gaps within your business in relation to GDP so you can address them using your CAPA process, during a self-inspection it’s also good to highlight the positives you find which can be fed back into your management review meetings and could also be fed back to employees should you find a positive where 1 or more are specifically responsible to help with morale.
The biggest benefit to conducting self-inspections apart from just conducting them effectively prevents a finding on the subject in an inspection but provided you address any non-conformities and gaps you identify effectively will also prevent these from being a finding too.
Self-Inspections can be conducted/scheduled in many ways, you can schedule it throughout the year by assigning specific GDP chapters/regulations to months/quarters, you could conduct one a year and cover all GDP and relevant regulations, you could do two a year covering all GDP and relevant regulations. I would recommend splitting it into quarters, however, you should schedule/conduct them, all of GDP should be covered by self-inspection across a 12-month period.
Self-Inspections can also be used for a specific chapter, regulation, or procedure at any time where you deem it necessary, for example, repeated deviations against a procedure could lead to a self-inspection on that procedure to potentially identify a gap or a current step in that procedure that could be the cause of the deviations. If you’ve found/come to our website for our blogs, stay and look at our training courses, we offer Audit training which goes into more detail on self-inspections as well as auditing other licence holders like your suppliers, customers, and outsourced providers.