Consultancy Archives - Page 3 of 8

Export & WDA(H) – Updated Guidelines:

by Sally Finlayson | Jul 14, 2021 | Blog, Export Training, MHRA, WDA(H), WDA(H)

As Great Britain (GB) are no longer part of the European Union (EU) since the 1st of January 2021 exit date. It is essential to ensure all the necessary changes have been made to remain MHRA compliant.

MHRA GDP/GMP Symposium Overview

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...

Do you have the correct licences for supply of Controlled Drugs?

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...

Reflections on a Summer Past

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...

MHRA Process Licensing Portal

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...

Who can be a Responsible Person (RP)?

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...

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Export & WDA(H) – Updated Guidelines:

MHRA GDP/GMP Symposium Overview

Do you have the correct licences for supply of Controlled Drugs?

Reflections on a Summer Past

MHRA Process Licensing Portal

Who can be a Responsible Person (RP)?

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