Departments and external stakeholders must work together to expedite recalls The above process overview highlights the main considerations when executing a medicinal product recall. When a notification of a recall is received by the MAH (marketing authorisation holder in Country for the medici…

Minimum checks required on medicinal product imported from an *EEA Country by a business in Great Britain (GB) If your business in GB is looking to import medicinal products from the EEA, there are a number of checks which must be performed by the Responsible Person, prior to release for sale …

Know Your Medicines Supply Chain When wholesaling in medicines, it is required to purchase, store and distribute medicinal products in such a manner that the quality, safety, identity, purity and efficacy of the pharmaceuticals is not compromised. The primary concern of the RP is patient s…

Staff training MUST be fit for purpose This post, previously on LinkedIn, received over 5000 likes! Placing 10s and 100s of procedures in front of your new starter does not really add any value to the individual, nor the company. These ways of working must change. Our solution would be to…

The Good Distribution Practice Challenges in Wholesaling & Freight Forwarding of Medicines The Responsible Person or Responsible Pharmacist, as referred to in some parts of Europe, is the person identified for ensuring the quality and safety of the medicinal product within their supply cha…

In my view, it is not acceptable to refer to any Change as temporary. You either Change or you don’t. It should be a well-structured and controlled Change from start to finish. I accept, we may face exceptional situations as in the above illustration, where a very immediate fix must be made.…