by Dean Tinklin | Aug 17, 2018 | Behind the scenes, Blog, Good Distribution Practice - GDP, RP, Training
Despite the MHRA’s guidance note 6 there is a lack of a clearly defined and standardised route into becoming a trained, experienced, and effective Responsible Person (RP), and consequently the MHRA are now placing a greater emphasis on the suitability of a licence holder’s RP, perhaps in an attempt to ensure that all roads eventually lead to the same destination or to gradually develop and define the necessary route, or maybe both…
by Adel Nagy | Sep 29, 2017 | Blog, Consultancy, GDP/RP, Good Distribution Practice - GDP, MHRA, RP, Training
The European GDP Guideline of 5 November 2013 requires that wholesale distributors have to appoint a Responsible Person (RP) for GDP. The RP is responsible for safeguarding product users against potential hazards arising from poor distribution practices. According to...
by Jackie (née Heneghan) Peck | May 12, 2017 | Blog, Consultancy, External Audit, Good Distribution Practice - GDP, Licence Acquisition, MHRA, Regulation, RP, WDA(H), WDA(H)
Do what I say not what I do, how many of us heard this from our parents & teachers or at least thought that it was one of their mottos? Unfortunately this seems to be a common theme in interactions with all sorts of official bodies as well, now I am not daft...
by Jackie (née Heneghan) Peck | Feb 21, 2017 | Blog, Good Distribution Practice - GDP, MHRA, Quality Systems, Regulation, RP, SOPs, WDA(H)
Risk Assessments and Self-audits should cover the whole of your GDP activities during the year. It is best to plan and ensure that you also conduct at least a couple of process audits. Prior to conducting risk assessments, you should look for evidence and discuss with...
by Jackie (née Heneghan) Peck | Feb 20, 2017 | Blog, Export Training, MHRA, Regulation, RP, Training, Transportation, WDA(H)
The MHRA inspectors have said that they are now focusing on the transport of medicines, and that more “Majors and Criticals” will be issued if UK wholesalers are not compliant. RPs have had over 3 years now to affect the changed required by current GDP guidelines. RPs...
by Ryan Watts | Oct 9, 2015 | Blog, RP
Outsourcing should be considered in small and large organisation where where an expert third party is more effective and economical. The alternative is to employ and train in-house experts or retrain existing team members. Quality Expertise can be sought in diverse...
