My name is Lynsay Hunter, and I am a GLP inspector in the MHRA inspectorate laboratories team. The laboratories group conducts a diverse number of inspections both internationally and across the United Kingdom.
GCP (Good Clinical Practice) Laboratories inspections
GCP inspections include laboratories conducting the analysis of samples collected from subjects involved in human clinical trials. This also includes the inspection of bioequivalence clinical trials needed for licensing of generic drugs.
GLP (Good Laboratory Practice) Laboratories inspections
The UK GLP Monitoring Authority (GLPMA) monitors non-clinical safety studies looking at the impact chemicals such as pharmaceuticals, agrochemicals, veterinary medicines, industrial chemicals, food additives, biocides and more have on the environment and human and animal health.
GMP (Good Manufacturing Practice) Laboratories inspections
GMP inspections cover contract laboratories performing GMP Quality Control (GMPQC) testing.
We have a huge variety of technologies, facilities and types of work to inspect and consequently are actively trying to find ways to communicate and engage with our stakeholders so you are aware of the types of issues we are encountering.
The laboratories team is pleased to announce that on Tuesday the 27th of February 2018 we will be holding another Laboratories Symposium at the Queens hotel in Leeds. As an agency, we place great importance on these events and view them as a key part of our communication strategy giving us an opportunity to engage with stakeholders to discuss topics that are important to us all.
This event provides a forum for stakeholders to meet the inspectors in a more relaxed setting, rather than just during formal regulatory inspections. This interaction works both ways as submitted questions and panel sessions also help us to understand your issues relating to regulated laboratory activities. These events also encourage stakeholders to come together to network with others from similar backgrounds and with similar experience.
We have reviewed the feedback from our previous events and looked at subjects which we feel are important to discuss based on recent inspection experience to create what we hope will be an interesting agenda, including this year content relevant to contract GMP Quality Control (GMPQC) laboratories as well as GCP and GLP facilities.
So, what are we going to talk about this year?
In addition to our regular update on how our systems and inspection strategies have evolved over the last 12 months we will also be exploring quality culture, including an overview of our expectations and current thinking regarding operation of quality management systems. We will be considering some interesting inspection findings on aspects of data integrity, quality oversight, governance and responsibilities. They include some hints and tips as part of a corrective and preventative action session.
The 2018 symposium will also include three parallel ‘break-out’ sessions to allow us to delve into more depth on GxP specific technical aspects from GCP, GLP and GMP. These sessions will be booked as part of the registration process. We also intend, in another first for us, to include some limited bookable slots for one to one discussions with inspectors.
Details on the event and the full agenda can be found here: https://mhralabs.co.uk/
We had positive feedback regarding the Inspector’s Desk last year so this will feature again. Please come and see us on your tea and coffee breaks. The inspectors are also likely to be found roaming free near the buffet!
This is really a great chance to share experience and to network with regulators and fellow professionals. We really hope that you can attend and we look forward to seeing some of you in February (if not before on inspection).