by Brian Lindsay | Sep 14, 2018 | Blog, Bona Fides, Brexit, MHRA
What do you want to do? Provide Information. When do you want to give it to us? Ummmm… OK, you might have been more definite in your final answer. But was it what the MHRA Inspector wanted to hear? Or see in your SOP’s? Particularly with regards to information on...
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...
