We are often approached by both new and existing Wholesale Distributors who are due an inspection or haven’t had an inspection since the current Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01). came into effect.
In particular, an organisation who hadn’t been inspected by the MHRA since 2011 asked, in 2014, us to carry out an audit against the new Guidelines to assess their compliance.
Although we were able to see that the organisation had made some changes to their processes to address the additional requirements, we identified non-conformities within their Quality System, Transport Validation and Supplier Qualifications. Some of their records were incomplete and training files did not reflect any additional training relating to the Falsified Medicines Directive or updated Standard Operating Procedures.
Dependant on the seriousness of the identified non-conformities, these types of issues could be considered to be major non-conformities and could have had an effect on the outcome of the organisations inspection and GDP compliance status.
The Pharmacy Consulting Solution
At the end of the audit, our Consultant walked through the findings of the audit with the organisation’s management, giving explanations as to what the non-conformities were and what the relevant clauses of the Guidelines required.
The organisation arranged with us to carry out onsite GDP training with key personnel to give a wider understanding of the requirement of current GDP Guidelines.
We issued a full audit report and corrective action plan form and advised the organisation on their risk assessment, root cause, corrective actions and corrective action timings.
Once implemented, we carried out a further external audit to assess the effectiveness of the corrective actions and reassess compliance.
We have arranged on-going training with the client to ensure that they keep up to date with the requirements of the Guidance and the Inspectorate.
With our audit, training and input, the organisation has peace of mind and is now looking forward to their inspection when they can demonstrate their compliance and knowledge of the current Guidelines.