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 Jackie (née Heneghan) Peck | Sep 11, 2017 | Falsified Medicines, Good Distribution Practice - GDP, MHRA, Regulation, Transportation, WDA(H), WDA(H)
You may have been supplied with medicines in the past by suppliers or organisations who sell or donate the medicines to you, however, if you are to ensure the supply chain is compliant and legal you must obtain a WDA. Where do you start? The first thing you need to do...
by Jackie (née Heneghan) Peck | May 23, 2017 | Blog, Brexit, Good Distribution Practice - GDP, WDA(H)
The UK triggered Article 50 of the Treaty on European Union on 29th of March 2017 and as a result all primary and secondary law ceases to apply to the UK from 30th of March 2019. Companies who hold centrally authorised “MA s” must proactively review their MA terms,...
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 | Apr 3, 2017 | Blog, Falsified Medicines, MHRA, Regulation, WDA(H)
The Safety Features Team have set up a mail box for queries you might have regarding the new FMD requiring the registering of products onto the new EMVO portal: [email protected]
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...