Victoria Pharmaceuticals Clinical Trial Manufacturing Service
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Transcript of Victoria Pharmaceuticals Clinical Trial Manufacturing Service
Fiona Taylor Clinical Trials Production
Pharmacist
Victoria Pharmaceuticals Clinical Trial Manufacturing
Service
Victoria Pharmaceuticals At Victoria Pharmaceuticals we pride ourselves on our product quality and a high level of customer service.
Victoria Pharmaceuticals Victoria Pharmaceuticals is a ‘Specials’
manufacturing unit within Belfast Health and Social Care Trust. Based on the Royal Hospital site.
Manufacture a range of sterile and non sterile specials.
Manufacture Investigational Medicinal Products
We hold a specials licence and an IMP licence granted by the MHRA.
Our Facility Our production unit was commissioned for use In 2010
State of the art facility. Sterile and non-sterile capability.
The IMP Production Process
Proposal / Idea Feasibility Options & Quotations
Project Plan Prepare
Documentation for regulatory submission
Sourcing of Raw Materials
Plan Production of Batches
Manufacture IMP Distribution
Stage 1
Proposal – Information from Investigator
Feasibility – Capacity planning
Quotation – Options provided
Stage 2
Project Plan – Timelines – Plan manufacturing / assembly process – Train staff to carry out processes – Distribution logistics – Temperature monitoring – Problem solving
Stage 3
Preparation of Documentation for Regulatory Submission – Technical agreement – IMPD – Placebo Dossier – Product Specification File – SmPC – Summary of product characteristics – TSE information
Stage 4
Sourcing of raw materials – Licensed product – Placebo components
Plan production of batches – Projected recruitment – Expiry of IMP – Number of sites
Stage 5
Manufacture of IMP – Planning production – Training staff – Preparation of documentation
Distribution – Multi-centre / single centre study – Is temperature monitoring required? – Cold chain distribution?
Previous, Current and On-going Projects
Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP2)
A Randomised Controlled Trial of Calcium Channel Blockade with Amlodipine For the Treatment oF Subcortical IschaEmic VasCular DemenTia (AFFECT)
A Randomised Double Blind Placebo-Controlled Clinical Trial of a Single Oral Cholecalciferol Treatment Against Surrogate End Point Biomarkers (SEBs) in Colorectal Cancer (CRC) Patients
A randomised placebo-controlled pilot trial of omeprazole in idiopathic pulmonary fibrosis (IPF)
Effect of vitamin D3 supplementation on insulin resistance and cardiovascular risk factors in people at high risk of type 2 diabetes and cardiovascular disease.
Problem Solving Change in active capsule colour Change in size of active tablet Active product discontinued Change in active tablet appearance
What can we do for you? Innovative product design Cost advice and analysis Bespoke labelling Manufacturing of clinical trial medication Blinding QP release Preparation of documentation for regulatory
submission Distribution throughout UK and Ireland Advice and support
Questions