My name is Bernadette Wilson, I’m a GDP Inspector, and I was a key member of the team which led the organisation and delivery of the MHRA GMDP 2017 Symposium. I am pleased to share the highlights of this well received event.
As with the GMP days we continued to make use of the MHRA event Application for Smartphones and other devices. This allowed delegates to participate in the interactive sessions and to access information associated with the event from their own devices. We aimed to enhance and encourage stakeholder engagement throughout the event and this has been well received since its launch.
The London event sold out very quickly and a large number of delegates also chose to attend the event in Glasgow.
Richard Andrews (Unit Manager Inspectorate Operations GMP and GDP), opened each and provided an update on Agency, International and Inspectorate activities. This included updates on the planned move of our headquarters from Buckingham Palace Road to Canary Wharf, the Operational Transformation programme and Brexit. As anticipated, we received several questions throughout the event about Brexit; all the latest information will continue to appear on our website (http://gov.uk/mhra)
GDP Operations Manager Peter Coombs, Senior GDP Inspector Madeleine Ault and GDP Inspector Jacqui Masayi, were the first presenters of the morning detailing an Inspectors’ view of Risk Management in the supply chain.
Jacqui advised delegates that when it comes to risk management “one size does not fit all”. She spoke about preventable risks such as company culture, strategic risks involving deal makers versus deal questioners and the numerous external risks licence holders are exposed to. She also focussed on the challenge of finding the balance between maintaining quality in a business area with increased commercial pressures
Madeleine followed with a key message about the identification and assessment of risk. Developing and implementing a plan of action and the constant review of the risks associated with the supply of pharmaceuticals.
To conclude this session Peter presented several scenarios in which the delegates were given the opportunity to use the event app and discuss the risks associated in each case and how they could be mitigated. The delegates worked well together to come up with some excellent examples of identifying potential risks and then developing mitigations.
Danny Lee-Frost Head of Operations, and Naseem Hudroge Intelligence Analyst, from the MHRA Enforcement section updated the delegates about the ongoing challenges and emerging trends the Enforcement team are currently facing including how they are working to protect the legitimate supply chain and the movement of controlled medicinal products. Danny went into detail about how the closer working relationships between Enforcement, the GDP team and Wholesalers has resulted in improved liaison, which in turn has led to a number of successful Enforcement Group operations. Danny also spoke about a recent operation in the North West of England and the seizures and arrests that had been made as a result of this improved joined up working.
The morning session was brought to a close by GDP Inspector Terry Madigan with his presentation covering security in transportation. Terry got the delegates thinking about supply chain vulnerability and pharmaceutical theft during transit. Terry highlighted that the information and statistics available show this is often an under reported issue throughout the world. Terry’s closing message placed an emphasis on knowing your supply chain, fully documenting the chain of custody and reporting stolen and missing pharmaceuticals to the relevant authorities.
The lunch break gave the delegates a further opportunity to network and speak informally with the inspectors. This was in addition to the ‘inspector’s surgeries’ that were also in place throughout the day and allowed the delegates to speak with the presenters and discuss relevant topics. The large screens located within the foyer displayed recently asked questions. This was also an opportunity for delegates to visit the various stands which included IPSE, PQG, Pharmaceutical Press, Cogent, the British Pharmacopeia and Securmed. Additional questions submitted through the event app will be reviewed and posted into the delegate area of the app.
The afternoon sessions got underway with Senior GDP Inspector, Cheryl Blake, Leading Senior GDP Inspector Tony Orme and GDP Operations Manager Phil Neale continuing the theme of transportation. Cheryl focused on the topic of transporting pharmaceuticals within ambient conditions and presented the audience with examples of temperature mapping results she had received. The delegates were given the opportunity to provide their opinions on the matter with roving microphones on the floor.
Tony moved the topic onto cold chain transportation, advising the audience that GDP requires that the selection of a container and packaging should be based on the storage and transportation requirements of the medicinal products; the space required for the amount of medicines; the anticipated external temperature extremes; the estimated maximum time for transportation including transit storage at customs; the qualification status of the packaging and the validation status of the shipping containers. Tony spoke of a case study featuring the consequences of failing to maintain cold chain transportation conditions correctly during transport.
Phil discussed export transportation activities through a range of interactive scenarios. This gave the delegates the opportunity to interact with each other and to test their own knowledge and experiences to reach their conclusions.
GDP Inspector Peter Brown, covered the popular topic of the top deficiencies within Good Distribution Practice activities. Data was obtained from a sample of 1428 sites from 2016. The data related only to major inspection deficiencies and found the top five areas were;
Chapter 1 Quality Risk Management – 47% of inspections
Chapter 5 Operations – 42% of inspections
Chapter 3 Premises and Equipment – 41% of inspections
Chapter 9 Transportation – 29% of inspections
Chapter 2 Personnel – 22% of inspections
Delegates were keen to hear from Senior GDP Inspector Peter Blundell who provided a brief update about the up-coming changes and impact of the Falsified Medicines Directive (FMD).
The public consultation is underway;
The MHRA have set up a dedicated email address to deal with any questions and queries specifically relating to the Falsified Medicines Directive which can be accessed at FMD.firstname.lastname@example.org
The day concluded with the ever-popular quiz which enabled delegates to utilise the event app and to test their knowledge and key learning points from the day.
With GDP being such a large, complex and varied business to operate within, the aim of the event was to include something for everyone whilst simultaneously delivering some core messages in areas where it is felt that focus is required.
The Inspectors enjoyed the opportunity of meeting with the delegates and were pleased to welcome regular delegates back as well as those attending for the first time. The event app has been updated to include the presentations. We have received a substantial number of positive comments and feedback and are pleased that you found the event useful and interesting. The post evaluation survey is open to delegates and we would welcome your responses to assist in the preparation of the 2018 event.
A huge thank you to all of you who attended, to the presenters and organisers, the events management team, Glasgow’s and our own Communications department – all of whom who contributed to making the event such a success. We are already looking forward to welcoming you all to the 2018 event.