by Jackie (née Heneghan) Peck | Jun 25, 2018 | Good Distribution Practice - GDP, MHRA, Regulation, Transportation
The last mile is hard enough to deliver GDP within Europe, but is impossible in countries such as Africa, especially land locked countries in the rainy season…
by Jackie (née Heneghan) Peck | Jun 19, 2018 | Brexit, GDP/RP, MHRA, WDA(H)
How well do you know them? Ten Questions which you need to ask yourself about your QP (Qualified Person) Are they involved enough in the changes and decisions made in your organisation ? Do they report to the decision makers ? Can they easily communicate with the...
by John Finey | Jun 11, 2018 | Blog, Brexit, MHRA, NHS
There have been major regulatory changes within the Medical Device market, with more coming in the form of the Medical Device Regulations (MDR) which is in the process of being implemented at the moment. The main change that has affected the market over the last...
by Jackie (née Heneghan) Peck | Feb 22, 2018 | Behind the scenes, Blog, MHRA, public speaking, WDA(H)
The recent GDP/GMP symposiums both concentrated on quality risk management, as compared to a previous emphasis on risk assessment. MHRA inspectors appear increasingly unhappy that pharmaceutical companies appear to be throwing together risk assessments, without...
by Jackie (née Heneghan) Peck | Jan 23, 2018 | Consultancy, EudraGMDP, Export Training, GDP/RP, Good Distribution Practice - GDP, MHRA, NHS, Pharmacist, WDA(H), WDA(H)
Are you a Wholesaler exporting Controlled Drugs or are planning to expand your product range to include Controlled Drugs? Do you hold a valid United Kingdom Controlled Drug Licence from the Home Office – if not you should and your WDA (H) may need to be varied to...
by John Finey | Oct 16, 2017 | Blog, Good Distribution Practice - GDP, Humidity, MHRA, WDA(H), WDA(H)
Looking back over the summer, my recollection is one of pretty cool and damp weather, but records do show that we at least had a few hot days. And with hot days come temperature deviations particularly during transportation and looking back over the deviations from...
