by Kimberley Peck | Feb 17, 2015 | Good Distribution Practice - GDP, Quality Systems
The new GDP guidelines on distributing medicines which are the regulations you must adhere to as a wholesale distributor use the word RISK 27 times. As a wholesale distributor you must access all risks within your business. The easiest way to complete this task is to...
by Ryan Watts | Dec 19, 2014 | Consultancy, Good Distribution Practice - GDP, Uncategorized, WDA(H)
Is yours up to date? Is it suitable for your business model? Do you have a change control procedure in place? Does your system work? Why is it needed? Stipulated in the European Guidelines of 2013 that any wholesaler must possess and use a QMS. Public health...
by Kimberley Peck | Dec 19, 2014 | Bona Fides, EudraGMDP, Good Distribution Practice - GDP, WDA(H)
Is a copy of a WDA(H) enough evidence to approve a supplier? NO! Evidence of a WDA(H) is just one of the steps required for supplier approval. If obtaining the product direct from manufacturer or from another wholesaler the authorisation is no longer enough. The...
by Jackie (née Heneghan) Peck | Oct 28, 2014 | Blog, Consultancy, Good Distribution Practice - GDP, RP, Training
If you have, recently, tried to register for the 2014 MHRA GDP symposium, you will have found it to be fully booked. If you have missed your space this year, why not register for one of PCL’s RP update courses? Our GDP/RP courses are held twice a month in the...
by Jackie (née Heneghan) Peck | Oct 3, 2014 | Blog, Consultancy, GDP/RP, Good Distribution Practice - GDP, Training
On the 12th August, 2014 the MHRA issued an e-mail stating their concerns that a significant number of major deficiencies are being identified where wholesalers have not read, understood or implemented the revised EU Guidelines on Good Distribution Practice. The...
by Jackie (née Heneghan) Peck | Oct 3, 2014 | Blog, Bona Fides, EudraGMDP, Good Distribution Practice - GDP, Pharmacy Suppliers, WDA(H)
As a Wholesale Distributor you must now verify that your suppliers are in possession of a valid authorisation AND that they comply with the principals and guidelines of good distribution practices. This will need to be described in your Supplier Qualification SOP and...
