by Ryan Watts | Jun 12, 2015 | Analyisis, Behind the scenes, Blog, Bona Fides, Business, Consultancy, EudraGMDP, Falsified Medicines, GDP/RP, Good Distribution Practice - GDP, Licence Acquisition, Open Courses, pharmacy business development, Regulation, RP, SOPs, Training, WDA(H), WDA(H)
Yesterday I had a call from a distraught pharmacist who desperately wanted to know how to go about growing his new pharmaceutical wholesaling venture which he had set up with a friend. Our conversation went as follows: Caller: “We have applied for a MHRA...
by John Finey | Jun 4, 2015 | Behind the scenes, Blog, Business, Consultancy, EudraGMDP, GDP/RP, Good Distribution Practice - GDP, Licence Acquisition, MHRA, pharmacy business development, Pharmacy Suppliers, Quality Systems, Regulation, Training, WDA(H), WDA(H)
For pretty much the whole of the last six months the team at PCL have been trying to make headway with certain issues thrown up by the EU Guidelines on GDP for Medicinal Products for Human Use (5th Nov 2013). On face value it is hugely helpful that there are common...
by Ryan Watts | Jan 14, 2015 | EudraGMDP
Since the issue of the current EU Guidelines on Good Distribution Practice (GDP) of medicines for human use, we have been asked by several distributors to review their quality system against the Guidelines. The most common gap, that we see, relates to qualification of...
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 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...
