Just a tiny refresher… are you approving suppliers and customers appropriately? We posted about this topic before, as it is business and licence critical. Bona Fides (Approval of Suppliers and Customers) Checks – how and why? Suppliers and customers are on either side of you in the supply chain, and if you supply someone who…

Wikipedia (other information sources are available, and recommended) states; Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a…

The Falsified Medicines Directive is a key focus for the UK Competent Authority (the MHRA) and it is expected that as a UK Pharmaceutical wholesaler that you are aware of this emerging regulation. The FMD comes into effect 09 Feb 2019, “Brexit” or not. For more information around Falsified Medicines and the coding, see our…

What is Pharmacovigilance? By Joan Mwanaka, BSc Did you know that every drug has a side effect? It has been reported that a drug without a side effect will not work! So, if drugs are supposedly causing side effects, why are they on the market, and how are these drugs monitored? Pharmacovigilance is the answer…

Every wholesaler should be actively subscribed to the medicine recall and drug alerts and be aware of their responsibilities for carrying out recalls within the time limits required. If no recall happens during the year the licence holder must carry out a dummy recall. This has historically been a big part of non-compliance with GDP, however…

With the Falsified Medicines Directive coming (slowly) to fruition, it will be pharmacies and wholesalers bearing the brunt of the changes in the continual pursuit of patient safety. Sultan “Sid” Dajani, Chairman of the Falsified Medicines Directive at the Royal Pharmaceutical Society,  and UK Representative for the Pharmacy Group of the European Union (PGEU), has kindly written…

  Does your GDP Quality Management System identify risks to patient and product safety? If not, why not? Need help? Then read on. The EU GDP Guidelines mentions risk and risk identification for the first time ever; 1.5. Quality risk management Quality risk management is a systematic process for the assessment, control, communication and review…

The MHRA regularly find that self inspections, which are required for GDP compliance, are either not carried out or are insufficient in their scope. The new regulations advise that third party inspections could be considered helpful, but cannot replace self inspection protocols. It is also agreed that the self inspection does not need to be…

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