** 2014 Update **
After being present at a number of MHRA inspections since these guidelines came in, PCL have had a number of calls from wholesalers who have been suspended for trade or whose inspection results weren’t great.
PCL can help you audit your current Quality System to be inspection compliant or can help you build and develop a more robust model.
Rather than going through a poor inspection why not call us on 01252 302342 to ensure you are up-to-date with the new guidelines.
PCL also offer training in GDP, the Roles and Responsibilities of the RP and Audit.
** END **
As I sit here and write this article, I sincerely hope that all those with a wholesaler license are well aware of what (2013/C 68/01) represents. It relates to the ‘New Guidelines on Good Distribution Practice of Medicinal Products for Human Use’ which are now live and active after being revised and published in March this year. There are a number of changes wholesalers needs to be aware about to ensure they remain compliant with the new guidelines. Failure to comply can result in the temporary suspension of a license.
So, are you aware of the changes?
Whilst it would take me a considerable to summarise all the change, the key areas of change relate to the:
- Quality Management System (QMS) in place
- The job description of the Responsible Person (RP) and your personnel training
- Storage facility and its suitability
- The technology capabilities necessary and required documentation
- Supply chain verification and necessary ‘Due Diligence’
- Inspection an audit protocol
- The ways medicines are transported from the facility
Of course, the formal copy of this document is available for use by wholesalers but do you know how to interpret the changes in order to be compliant?
Pharmacy Consulting Limited are experts in their field and provide consultancy services to wholesalers in both the UK and the EU. We can assist in a variety of ways including the development of a QMS, RP training, temperature mapping and external audits just to name a few. For some of you, now may simply be a good time to complete an overall review of your facility while the changes are fresh and recent. Call us before you find out your site is non-compliant.
Pharmacy Consulting Limited can be contacted on +44 (0) 1252 302 342.