Content Uniformity by Transmission Raman – Gaining Regulatory Approval
Transmission Raman spectroscopy (TRS) is an alternative to HPLC for content uniformity (CU) analysis that has many attractive benefits, and is increasingly being used by pharmaceutical manufacturers for CU testing.
Transmission Raman spectroscopy (TRS) is an alternative to HPLC for content uniformity (CU) analysis that has many attractive benefits, and is increasingly being used by pharmaceutical manufacturers for CU testing. TRS takes seconds per sample, is robust to sample variation, needs no preparation, solvents or consumables and saves significant cost and resource per batch. An important factor for adoption of the technique is the regulatory approval of TRS CU methods and, as submissions are made with regulators, it is important to take the correct strategy.
This webinar is in two parts; one part covers the preparation of a validated transmission Raman spectroscopy submission to a regulatory body, and the second is a worked-through example of building a tablet method. Two of the speakers, Phil Doherty of Process Analytics and Gemma Robinson of Acorn Regulatory Consultancy Services, will discuss the formation of a cogent regulatory strategy for summarising Transmission Raman methodology and results in a Quality Overall Summary report suitable for filing as a new submission as part of a new Common Technical Dossier or a Type II variation. Julia Griffen of Cobalt Light Systems will show an example of the comprehensive quantification of pharmaceutical tablets consisting of 5 components (3 APIs and 2 excipients) in a cold and flu formulation. The concentration of individual components ranged from 1 to 85% w/w. Each tablet was measured non-destructively for 12secs.
Content Uniformity Application of Transmission Raman Spectroscopy; Comprehensive Analysis of Complex Pharmaceutical Formulations
Dr Julia Griffen, Cobalt Light Systems
Julia Griffen1, Andrew Owen1, Pavel Matousek2
1Cobalt Light Systems, Milton Park, Abingdon, Oxfordshire, UK, 2Rutherford Appleton Laboratory, Harwell Oxford, UK
Transmission Raman spectroscopy is a powerful tool for content uniformity testing in pharmaceutical manufacturing, enabling rapid whole-tablet/capsule sampling by non-destructive means.
Herein we discuss advances of TRS technology, showcasing the ability to measure, model and quantify complex pharmaceutical tablet mixtures effectively and efficiently and highlighting the speed, ease of use and broad application scope. We present comprehensive quantification of pharmaceutical tablets consisting of 5 components; 3 APIs and 2 excipients. The concentration of individual components ranged from 1 to 85% w/w in the formulation. Each tablet was sampled for 12s twice. The alternative extraction and HPLC procedures are complicated and take almost 2 days to complete per CU test.
The ability to predict such complex mixtures quickly and comprehensively is a compelling reason to adopt this technology for quality control in the pharmaceutical industry.
A Roadmap/Overview to filing Regulatory Transmission Raman Spectroscopy Methods; Adopting a Pragmatic Approach
Phil Doherty1, Gemma Robinson2
1Process Analytics Ltd., 22 Whitepoint Avenue, Cobh, Co. Cork, Ireland, 2Acorn Regulatory Consultancy Services, Suite 6 Powerstown House, Gurtnafleur Business Park, Clonmel, Co. Tipperary, Ireland
Preparing your validated Transmission Raman spectroscopy for submission to a regulatory body can at first appear to be a daunting task. Herein we discuss the formation of a cogent regulatory strategy for summarising Transmission Raman methodology and results in to a Quality Overall Summary report suitable for filing as a new submission as part of a new Common Technical Dossier or a Type II variation.
Dr Phil Doherty
Phil attained an MChem in Chemistry and Physiology at the University of Sunderland prior to joining Pfizer Global R&D, Sandwich in the UK in 1991. There he worked for 12 years in the Technology Development Group developing Process Analytical Technology systems for API and Solids Manufacturing. Phil was the recipient of the 1997 AAPS Outstanding Manuscript of the Year for Quality for pioneering work on the design of the world’s first Online NIR Blend analysis system. Subsequently Phil worked as the PAT Manager at the Pfizer Loughbeg Drug Product Plant delivering innovative PAT technologies such as Model Predictive Control of High Shear Wet Granulation and Inline systems for Continuous Processing for Pfizer’s biggest selling product. Since leaving Pfizer in 2012 Phil is now the Lead Consultant at Process Analytics Ltd, a company specialising in providing total Process Analytical Solutions and QbD services to the Pharmaceutical Industry:
Since its establishment in 2012, Process Analytics has successfully provided expert support to Sanofi Genzyme, GSK, Pfizer, Eli Lilly, Gilead Life Sciences, Actavis, Teva, Merck Millipore & DePuy Synthe.
Dr Gemma Robinson
Gemma has a BSc in Analytical Science from Dublin City University, in Dublin, Ireland and a PhD also from DCU. Her PhD included collaboration with Chiron Corp, San Francisco, CA and involved the separation & identification of important biomarkers using HPLC and Capillary Electrophoresis techniques.
Having initially worked within the Quality Department of the Veterinary manufacturing company; Norbrook Laboratories, in Northern Ireland, she subsequently moved into Regulatory Affairs and was Senior Regulatory Affairs Officer for Bioglan Generics Limited, in Tipperary, Ireland for 5 years. Gemma earned a sound understanding of Pharmaceutical manufacturing and the importance of developing strong business relationships with strategic partners.
In 2002, Gemma established Acorn Regulatory, which provides Regulatory Affairs consultancy services to Pharmaceutical & Medical Devices manufacturers globally. In 2011, she was awarded the ‘Female Entrepreneur of the Year Award' by the South East County Enterprise Boards in Ireland. In 2012, she was shortlisted for the Inspiration Award by TOPRA - The International Organisation for Professionals in Regulatory Affairs.
Dr Julia Griffen
Julia attained an MChem in Chemistry Management and Industry from the University of York in 2009. She spent the final year of her undergraduate degree on an industrial placement at GSK in Stevenage, UK. Working in process R&D within the Process Analytical Technologies and Chemometrics (PAT&C) group most of her work focussed on NIR process monitoring technologies and analysis. She attained her PhD in 2013 from the Centre of Sustainable Chemical Technologies at the University of Bath, UK. Her PhD was a joint project between Chemistry and Chemical Engineering focussing on the isolation of fermentation products, followed by synthetic manipulation through to novel chiral sugars with biological activity.
Julia took on the role of Application Scientist at Cobalt in October 2013. Her role is predominately focused on the TRS100 and its pharmaceutical applications. She has input into many parts of the products lifecycle including; instrument testing, development, validation, installations, demos, training, analysis of customer samples and support.
Most recently Julia has presented Cobalt’s latest experimental results at SciX 2014. ‘Transmission Raman: How fast can you go?’ This work has now been accepted for Publication in the RSC journal Analyst. The article is open access.