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...
by Jackie (née Heneghan) Peck | Oct 3, 2014 | Blog, Good Distribution Practice - GDP, Transportation, WDA(H)
Since the application of the Falsified Medicines Directive in January, 2013 there is a new requirement that anyone involved in the export or holding of medicinal products intended for export, for wholesale distribution, now require a Wholesale Distribution...
by Jackie (née Heneghan) Peck | Aug 13, 2014 | Blog, Good Distribution Practice - GDP, Quality Systems
During the course of our work we often find that there is little understanding of what a quality manual is and what should be in it. Simply, the quality manual forms the basis for your quality system and is the ‘what you do’, whereas the SOPs are the...