Registering as a Wholesale Distributor of Medicines in the UK with the MHRA
A UK based company with an ambition to be a leading exporter of pharmaceuticals to the Latin America approached Pharma Experts for support and advice on how they could acquire a Wholesale Distributors Authorisation (aka WDA (H) or Wholesale Dealers Licence) after a disastrous first visit from the MHRA.
During the initial visit to the company’s state of the art distribution site, the MHRA Inspector raised concerns over the business model and the Quality System. In addition a total of 30 deficiencies were identified. To make a bad situation worse, the Responsible Person failed to demonstrate an understanding of the principles of Good Distribution Practice.
The Pharmacy Experts Solution
As a part of its Remediation Service, a Senior Consultant and ISO 9001 Lead Auditor from Pharma Experts arranged a visit to the client’s site to ascertain the scope of the project before a proposal could be made.
The site visit and gap analysis based on EU 2014 Guidelines picked up the same issues raised by the inspector in his report. In summary:
1. The Quality System in place was not fit for purpose. It was supplied by IT Company as a free add-on to its IT bundle which the company had purchased and was now tied in with a contract of 12 months.
2. Inadequate temperature mapping had been carried out using minimum and maximum thermometers.
3. Both the owner and RP had attended training with a third party agency associated with the IT Company. However, the quality of the training was questionable as the basic principles of GDP had been missed.
The Pharma Experts Remediation Service was commissioned by the client and one of its Senior Consultants took over as the company’s RP. Pharma Experts then implemented the agreed action plan developed to bring the client’s organisation the required standards.
Practical assistance was given to the client to improve the layout of the site and a new bespoke Quality System complete with working procedures for the ordering, receipt, storage and distribution of medicines was developed.
A comprehensive Temperature Mapping exercise was performed over 14 days ( 7 empty and 7 days loaded) with calibrated data loggers.
Pharma Experts was proactive and provided both on and off-site training on the principles of GDP and Falsified Medicines for both warehouse staff and delivery drivers.
The company was granted a WDA (H) without a second visit from the MHRA solely due to the quality of standards which replaced the existing set up.
The client started trading and complimented Pharma Experts in the way it handled the project within the tight schedule.
Pharma Experts is now working closely with the Managing Director to ensure they gain adequate experience to take over as RP within a period of 12 months.
Morale of the Story
The Latin term ‘Caveat Emptor’ meaning ‘let the buyer beware’ comes to mind. Although it may cost marginally extra, always get advice from experts as you may end up paying more in the end.
Registering as a Wholesale Distributor of Medicines can be a tricky business so its best to get advice from the experts and not some rookie organisation.
Remember what your mother used to say, “Buy cheap, buy twice”
* Based on true events. Names and addresses have been removed to protect the innocent.