When you are named as a Responsible Person on a Wholesale Dealers’ Licence you have the responsibility to demonstrate that all the distribution activities carried out comply with GDP.
When a MHRA Inspector visits, they will want to see that you have a clear understanding of the business and oversight of all wholesale activities carried out under the WDA(H).
The latest data from MHRA showed that four out of the top five deficiencies recorded at inspections directly related to issues of non-compliance attributable to the RP.
1. Inadequate Quality management systems and review processes
2. Responsible Person failing to adequately carry out their duties
3. Inappropriate supply, failure to correctly qualify the customer base
4. Inadequate management of outsourced activities
The root cause of all these issues ultimately comes down to the RPs not having an effective self-inspection programme that considered all GDP activities and effective audits of outsourced activities.
This practical course is designed to enable you, as a RP or Quality professional, to develop confidence in how you manage the audit process to get maximum value from your audits.
With a well-designed and structured audit plan based on the techniques covered in this course you will be able to face any regulatory or external audit with confidence. This assurance will stem from the knowledge that your audits are well planned, effectively conducted and reported, with the appropriate corrective actions captured.
An effective audit programme is key to maintaining inspection readiness as you systematically review all the GDP activities carried out under the WDA(H).
Regulators want to have the reassurance that between their inspections your company will comply with GDP. If during an inspection it is evident that self-inspection audit plans are of limited effectiveness and there are gaps in the audit schedule, you will be classed as a higher risk organisation and subject to more frequent inspections.
Being able to demonstration that you have an effective risk-based audit programme across the full scope of the business gives a confidence to Regulators or external auditors that your company has a positive Quality mind set and are committed to complying with GDP. By being able to demonstrate your auditing programme’s scope and effectiveness, you should be classified as a lower risk company with a higher level of reassurance in how you operate between inspections.