After a number of non-conformities were identified during an MHRA inspection, a WDA(H) holder contacted us for advice and assistance.
The Pharmacy Consulting Solution
PCL, firstly, reviewed the MHRA post-inspection report and, with the client, addressed each of the non-conformities, deciding the best corrective actions and realistic time-lines for putting the actions into place. We then helped the client with their corrective action report which was submitted to the MHRA within the required 28 days.
The client then attended one of our GDP/RP Training Days which gave an insight into the requirements of the Guidelines on Good Distribution Practice of Medicinal Products for Human Use and how to achieve compliance.
We then carried out a full gap analysis of the client’s quality system and activities against the Guidelines. From this, we were able to help the client establish an updated Quality System that meets the requirements. Once the corrective actions and revised quality system were established, we went back to the client and carried out an audit, ensuring that the Quality System was effective and that the client had remained compliant.
Our input and assistance with the submission of the corrective action plan enabled the MHRA to issue the client their renewed WDA(H). By training and working with the client to improve their Quality System and activities they are able to remain compliant.