Casgevy
The MHRA is the first Regulatory body in the world to authorise a Crispr-based gene therapy.
GPhC Standards do you know what you must adhere to when operating a pharmacy? Part 1, Principle 1 Governance arrangements
When operating a pharmacy, the General Pharmaceutical Council (GPhC) will come and inspect you against the pharmacy standards, do you know what evidence you will need to present to demonstrate how your pharmacy adheres to the standards?
Common Trends from 2023 GPhC Inspections
Now we have started 2024, this blog highlights the common trends identified from inspections carried out in 2023.
MHRA Extension of GMP and GDP certificates validity period
The UK regulator for medicines, medical devices and blood components for transfusion in the UK, The Medicines and Healthcare products Regulatory Agency (MHRA) have further extended the validity period of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) Certificates.
Training Courses at PCL
Pharmacy Consulting is one of just five providers approved by cogent skills and the MHRA to deliver the responsible person in GDP course.
Wholesale Dealing in Veterinary Medicines
In order to legally run a business that deals with the wholesale of animal medicines (veterinary medicinal products) you must obtain a veterinary medicines Wholesale Distribution Authorisation (WDA(V)) from the Veterinary Medicines Directorate (VMD).
Risk Assessments and Detectability
PCL as a company has started to see that detectability has become a requirement when conducting Risk Assessments. There is more than one way to incorporate detectability in your risk assessments but below is a suggestion that could be used. When conducting a risk...
How confident are you that your team are working to GDP ?
Good Distribution Practice applies to the whole business, so if you have a WDA, one of the requirements is that you work to GDP. As part of your licence terms, it is the responsibility of the RP to ensure that all staff involved in GDP activity are trained in GDP.
Cogent Gold Standard Responsible Person Training
Cogent Gold Standard Responsible Person Training – Our three day online or face to face training course is run on an monthly basis.
Post Brexit Changes
It is quite easy to think that Brexit must have been done by now, but the reality is that it isn’t. I was reminded of this doing my trawl through the daily GOV.UK Brexit email.