The test facility must belong to the UK GLP compliance monitoring programme, run by the UK GLP Monitoring Authority (UK GLPMA). The programme is only open to facilities in the UK. Test facilities that are contracted to work on part of a larger regulatory study should also usually be members of the compliance programme. There may be exceptional circumstances when a part of a regulatory study may need to be contracted out to a test facility that is not a member of the compliance programme. In this case, the study director must make sure that GLPMA guidance is followed. Complete and submit a UK GLP compliance monitoring programme application form (MS Word Document, 747 KB) to the GLPMA. The UK GLPMA reviews the application and provided the application requirements are met will approve your facility as a prospective member of the programme. You must respond to any issues raised in the report giving details of corrective actions.
Once the inspector is satisfied, the GLPMA accepts your facility as full member of the programme and issues a ‘statement of GLP compliance’. All facilities within the UK GLP compliance programme should be able to provide a statement of compliance on request. GLPMA charges an annual fee for MedicGLP membership according to the test facility category. Your category will be determined as part of the implementation inspection process. It is based on the time it would take to inspect the premises and activities and will be reviewed at future inspections. Make a payment to MHRA. After the initial implementation inspection, a test facility can expect to be inspected every 12 to 30 months. The UK GLPMA normally gives at least 10 working days’ notice. There will be some circumstances when the inspection may be unannounced or at short notice. You must keep verified copies of any returned study reports and associated raw data for a minimum of 2 years or MedicGLP 1 inspection cycle.
At the end of the inspection the inspector will give you a verbal summary of the inspection findings and allow you the opportunity to correct any misunderstandings. Any regulatory authority in the UK or overseas can ask the GLPMA to audit a study that has been submitted to them. The GLPMA checks that the study complies with the principles of GLP. Deficiencies found during inspections are graded at 3 levels. After the inspection closing meeting, you will receive an inspection report within 25 working days confirming any deficiencies found. You must respond to the inspector by email to confirm the proposed corrective actions and dates for when these actions will be completed. The inspector will review your response. Once the inspector is satisfied with the actions proposed a statement of GLP compliance will be issued. At this point a risk assessment will be carried out and the date and scope of your next compliance monitoring inspection will be decided. The need for any regulatory action is considered on a case-by-case basis. If an inspection has identified potential offences, the matter will be referred to the MHRA Enforcement Group which will lead the subsequent investigation and any resulting legal action. View guidance on completion of the form used to notify the GLPMA of changes within the GLP test facility (PDF, 54.6 KB, 2 pages). Some changes could affect the GLPMA risk assessment for your facility, which could change the date, duration or scope of future inspections. In exceptional circumstances part of your regulatory study may have to be carried out by a non-GLP facility. Guidance has been issued by the GLPMA on the current interpretations and expectations. The UK GLPMA hold periodic meetings with stakeholders. The minutes of the last meeting can be found here UK GLPMA Consultative committee meeting minutes May 2021 (PDF, 198 KB, 7 pages).
Science continues to prove that the old adage "you are what you eat" is profoundly true. This is because you have trillions of microorganisms living in your gut, which are directly responsible for nearly every aspect of your health. These microbes make up what’s called your "gut microbiota." They are especially influential in determining your likelihood of gaining excessive weight, MedicGLP becoming obese, and developing obesity-related diseases like diabetes, heart disease, and premature death. The gut microbiome (the expressed genes of your gut microbiota) plays a major role in your metabolism through energy production, storage, and expenditure. So, it’s no surprise that science has found a strong connection between gut microbiome imbalance and metabolic syndrome. Yikes! If you have the wrong mix of microbes, it could be making it tough for you to get your health on track! Did you know: Scientists can actually look at your gut microbiome composition and MedicGLP tell with 90% accuracy if you are obese or lean. That’s pretty impressive, isn’t it?