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...
by Adel Nagy | Sep 29, 2017 | Blog, MHRA, WDA(H)
Do you want to become a WDA holder? Do you need help with the application process? Do you need to add a variation to your licence? Do you need to apply for EU Common Logo for your company? The use of the portal is not simple, but PCL can provide you help with any of...
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...
