BCI Supply Chain Workshop Thursday 13th October, Belfast Harry Lyness Operations Manager for Movianto N.I.

Legislation and Adherence to GDP Movianto - Largest Pharmaceutical Distributor in Europe. Pre-Wholesaler of Specialist Medicines to Hospital Pharmacy / Wholesalers (and others) Movianto - Extension / Partner of the Manufacturer. Harry Lyness Operations Manager for Movianto N.I.

Legislation & Adherence to Good Distribution Practices The Pharmaceutical Industry is very highly regulated by the MHRA (Medicines Health Regulatory Authority) The MHRA is the Government Agency responsible for ensuring the safety, quality and efficacy of medicines in the UK. Movianto holds a Wholesale Dealer’s Licence issued by the MHRA Harry Lyness Operations Manager for Movianto N.I.

Legislation & Adherence to Good Distribution Practices The MHRA will conduct audits of wholesalers to ensure adherence to Good Pharmaceutical Distribution Practice (GDP) and that product integrity is maintained at all time. Failure to adhere to GDP guidelines can result in suspension or revocation of licence and/or prosecution of company and of RP(s) individually which would effectively put the company out of business. Harry Lyness Operations Manager for Movianto N.I.

Supply Chain Logistics When I leave my car in for repair at Nissan (who have an excellent supply chain) they may tell me they need a part from Japan – ‘ it’ll be here tomorrow afternoon.’ And generally it’ll arrive on time and the repairs completed – but if it doesn’t arrive it may be an inconvenience but that’s all. Goes into more detail. -M UK have 160 chilled vehicles in total – Split into equivilent groups (same size, same refrigeration system, same monitoring system etc) - 10 different types of vehicle -Some vehicles of the same make and model might have different refrigeration systems – these would then become a different group for validation -M UK don’t have engineers so validation of the actual chilling units was not possible – validation of the monitoring equipment (Transcan and Masternaut) and storage area of the vehicle instead -2-8 validation and testing of ambient area (10-25) can’t be validated as there is no means of controlling the conditions. -The validation plan goes into detail for each section -Design Qualification is the User Requirements (go into in the next section), the vehicle specifications (should be drawn up and agreed before purchasing any vehicles), supplier assessments (companies supplying the vehicles not the manufacturers) -Every vehicle should undergo IQ and OQ (covered in more detail later) to check that the groupings defined are accurate, monitoring probes are calibrated, monitoring system is set up the same way -A sample of each group should undergo PQ (again, covered in more detail later) Harry Lyness Operations Manager for Movianto N.I.

So - What do we mean by Product Integrity? When the end user is a patient in a hospital bed – supply chain management takes on a new meaning. So - What do we mean by Product Integrity? Delivered on time, in full and in the correct condition 100% accuracy every time. -Not much detail included, just an overview of what is required and the approach that is going to be used – lists different makes and models of vehicles and the temperature requirements (2-8, 10-25?) and what approach will be followed IQ/OQ/PQ Harry Lyness Operations Manager for Movianto N.I.

Distributor/ Wholesaler Cycle of events with Medicinal Products Manufacturer Developing, clinical testing, producing, packaging Distributor/ Wholesaler Procuring, receiving, storing, processing, delivering Hospital/ Retailer Ordering, storing, supplying M UK use 5 different suppliers depending on the size of vehicle As mentioned on the previous slide, these should be drawn up and signed off before purchasing the vehicles – attached specifications to the document The Patient Consumption & use Harry Lyness Operations Manager for Movianto N.I.

Supply Chain Management As an example we distribute a product manufactured in Switzerland which is used to treat severe Sepsis . Severe Sepsis – is a serious medical condition involving infection and generalized inflammation, treated in the Intensive Care Unit (ICU) M UK use 5 different suppliers depending on the size of vehicle As mentioned on the previous slide, these should be drawn up and signed off before purchasing the vehicles – attached specifications to the document Harry Lyness Operations Manager for Movianto N.I.

Supply Chain Management This product is over £600 for a single 20mg pack and has to be kept between +2 – +8 degrees Celsius at all times. Under no circumstances can Movianto be without this (unique) product or similar items. (manufacture issues must controlled and communicated to Pharmacy well in advance) Resilience of supply chain.. Stock holding Plans with Manufacturer to fly it direct from Source This is where the testing starts Can then calculate the thickness of walls and roof to ensure the insulation is the same on each vehicle Harry Lyness Operations Manager for Movianto N.I.

Supply Chain Management Movianto invest to ensure pharmaceuticals are handled in the correct manner... In particular the cold-chain maintenance back-up condensers, dual warehouses, dual fridges and back-up generators etc. Not to mention servicing, maintenance, calibration and validation of all measuring equipment by independent UKAS accredited sources. 24/7/365 Alarm monitoring and call-out list. Temperature monitoring equipment should be built to European Standard EN 12830 class 1 M UK use a system called Masternaut – temperature and location of every vehicle can be tracked ‘live’, alarms can be set for each vehicle and alerted to specific teams If more than one sensor is installed, raise the temperature of each one individually to check they are wired correctly (front is front, rear is rear) Harry Lyness Operations Manager for Movianto N.I.

Supply Chain Management Similarly with transportation – vehicles must be equipped to maintain product integrity.. Real-time temp monitoring Back-up equipment etc This audit trail can be requested at anytime by Hospital Trusts, Manufacturers or the MHRA even several years later. -Carried out during vehicle service every 6 months but not always to a traceable standard -Specify pass criteria and should be traceable to a national standard (UKAS in UK) -If print outs can be in graphical format, the graph axis need to be defined -Front and Rear temperature sensors, any other sensors such as door opening or defrost? -Front at 2-8 with 10 minute delay but no rear alarm because rear can be chill or ambient Harry Lyness Operations Manager for Movianto N.I.

Supply Chain Management ‘In my opinion, Investment (which needs to be reflected in the cost of the service provided) being taken out of the supply chain maintenance will increase the risk to product integrity and ultimately patient safety.’ -To ensure the set up of the temperature system can’t be changed by unauthorised personnel -To ensure that the driver and relevant staff at HQ are notified of an excursion -Check that all formats for producing temperature data are showing the same results Harry Lyness Operations Manager for Movianto N.I.

Supply Chain Maintenance Imagine the scenario..... You here a short news bulletin whilst driving to work relating to a person that had died at a local hospital after taking a reaction to some medication. You disregard it but feel pity for the family of the person. Several days later your company is asked to provide evidence that a drug you supplied had been stored and transported within the manufacturer specification -Check that the systems are able to store data and that the data has not become corrupt or changed over time -Check that the temperature system is not affected by low levels of Radio frequency and electro-magnetic interference Harry Lyness Operations Manager for Movianto N.I.

Supply Chain - Question? What evidence could we produce to prove cold-chain maintenance had been maintained from the point of despatch to delivery at hospital pharmacy for any product??? Harry Lyness Operations Manager for Movianto N.I.

Any Questions? Any Questions? Harry Lyness Operations Manager for Movianto N.I.