Category Archives: Publication

Majority of deviations raised result from poorly written procedures Procedures give us direction, structure and consistency in how we perform our daily tasks in ensuring medicines are manufactured and handled with the utmost care. They are a requirement to comply with our regulations, where …

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…