Patient safety is paramount

Patient safety is paramount

Derek Buchanan, CEO at Episys,talks about pharmaceutical labelling in the UK and compliance to MHRA guidelines…


The MHRA (Medicines and Healthcare products Regulatory Agency) is a government body concerned with effective regulation of medicines and medical devices to safeguard the health of millions of people every day. Software solutions used by commercial pharmaceutical companies for their labelling operations are very much under the MHRA’s regulation as clear, concise and precise labelling is of paramount importance to patient safety. 


Software vendors must design their solutions to meet the exacting requirements of the MHRA for security, integrity and accuracy and be able to provide documented evidence to validate that the application has undergone rigorous testing to the satisfaction of the MHRA and subsequently be certified by the vendor as a robust and reliable solution.


A major challenge for the pharmaceutical supply chain throughout the world is that years and years of paper trail detail produces an overwhelming amount of data for one producer to keep track of, let alone the man hours associated with keeping data captured, organised and useable. When coupled with the number of manufacturers who ‘touch’ a single ingredient used to make the final product, the task of gathering this information is daunting to say the least. As a result, careful attention must be paid to the management of the information collected and the effective transfer of information along the chain. 


Today we have access to innovative new technologies and solutions that can help automate the process of trace/track accountability. From raw ingredients to processing, from the wholesaler to the pharmacy, track/trace systems provide visibility and support the company’s validation of their procedures and protocols.


The MHRA here in the UK has called upon all players and stakeholders to maximise their efforts in taking responsibility for ensuring that a secure and safe supply chain is in place to best safeguard public health.


At Episys, our solutions and processes are MHRA compliant and our continued commitment to accuracy and quality has provided our NHS clients with mechanisms to help them get the best possible medicines to their patients.


Our clients in the UK are being as proactive as possible to ensure that they have robust procedures in place that will allow them to provide the best possible array of tracking and traceability mechanisms to comply with MHRA guidelines.  Here it is more about keeping products out rather than having anything in the supply chain that could be a problem. 


The MHRA is keen to move to a paperless environment and make the most of electronic systems such as our Ultimate Platinum module. This would remove the need for banks of A4 folders containing photocopies of batch sheets and enable label printing and batch sheet process to be combined into one system, critically reducing transcription errors. 



Stephanie Cornwall
Stephanie Cornwall