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cGMP Resources


Test and Equipment List:
cGMP Drug Development Support Services (CMC)

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cGMP Drug Development Services Brochure

Tepnel Pharma Services specialises in the provision of Quality Control pharmaceutical testing in support of drug development.
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An independent stability testing hub

The best partners have a different mind-set; we provide an engaged personalised, accessible and thoughtful service that supports you for the lifetime of your stability management requirements.
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The development and validation of QC analytical techniques – 3 case studies

Over 10 years experience in peptide analytical method development and validation. Tepnel Pharma Services has developed superior, complex, difficult methods for a variety of peptide products.
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Inhalation product testing

Tepnel Pharma Services provides the resources and capability to physically and chemically characterise an inhaled product during development or release according to the established protocols of the ICH, FDA and European agencies.
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White papers and case studies

Aggregation analysis of biopharmaceutical products – use of light scattering technologies for gel permeation chromatography – size exclusion chromatography
February 2018, David Jardine and Alex McDowall, Tepnel Pharma Services

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Brexit – Planning for regulatory preparedness and continuity of supply to the UK, outside the single market for medicines.
February 2018, David Scott, Tepnel Pharma Services

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How do you create a data integrity culture?
March 2016, by David Scott, Tepnel Pharma Services.

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A review of outsourcing business models in the CRO space.
March 2016, by Dr Vikki Renwick, Tepnel Pharma Services.

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Batch release testing: Get ready for new requirements.
February 2016, by David Scott, Tepnel Pharma Services.

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Making the Right Choice – David Tudbury and Vikki Renwick at Tepnel Pharma Services look at the trends in pharmaceutical outsourcing and consider the key drivers for customers when choosing an outsourcing partner in today’s challenging financial environment.
Summer 2010, by David Tudbury and Vikki Renwick, European Pharmaceutical Contractor.
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The sterility test – Brian Alexander, director of regulatory compliance at Tepnel Research Products & Services, assesses the benefits of microbiological sterility testing using isolator technology.
May 2010, by Brian Alexander, Manufacturing Chemist
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Harmonized microbiology methods, Dr Martin Cockcroft, Operations Manager at Tepnel Pharmaceutical Services, an established business of Gen-Probe Inc., speaks to Pharmaceutical Technology Europe about harmonized microbiology methods.
October, 2009, by Martin Cockcroft, Pharmaceutical Technology Europe.
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Audit and Impact.
Winter 2009, by Andy McCallum, Pharmaceutical Manufacturing and Packing Sourcer.
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Identifying supplier deficiencies.
June 2009, By Andy McCallum, Brian Alexander,
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Establishing a Successful CRO–Client Relationship, How to avoid common problems between the client and CRO.
May 01, 2009, By Emma Waite, BioPharm International, Volume 22, Issue 5.
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Outsourcing’s Evolution from Commodity to Partner, Can the historical industry and vendor service relationship change to one where both parties benefit?
Aug 01, 2008, By Dave Scott, Applied Clinical Trials

Handling difficult samples in bio-analytical chemical analysis, Analysing difficult samples is fraught with problems. Consideration of the thought processes, prior to picking up a pipette, will help to circumnavigate some of the pitfalls.
Jun 01, 2008, By Jim Hillier Pharmaceutical Technology Europe.
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Stability Testing of Biopharmaceuticals.
Spring 2008, by Dave Scott, Pharmaceutical Manufacturing and Packing Sourcer.
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Cleaning validation the holistic way – Applying a holistic approach to cleaning validation can be achieved through clear and focused methodology. Andy Maitland, business development manager for Tepnel Research Products and Services, outlines exactly how this is possible.
May 2008, by Andy Maitland, Cleanroom Technology.

How to Conduct an Audit of an Outsourcing Provider – There are several considerations to keep in mind when auditing an outsourcing provider.

April 2008, by Andy McCallum, BioPharm International Supplements.

Supporting critical Phase I–IV clinical studies by outsourcing supporting elements, What are the outsourcing trends and challenges facing the pharmaceutical industry when looking to outsource difficult services such as bioanalysis? Critical factors for identifying the ideal outsourcing partner and building an accretive and rewarding relationship are considered.
March, 2008, By Vikki Renwick, Pharmaceutical Technology Europe
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A practical approach to disinfectant tests, Dave Scott, general manager, and Brian Alexander, director of Quality & Regulatory Affairs at the pharma division of Tepnel Scientific Services, consider a suitable disinfectant testing approach for the pharma.
May, 2007, By Dave Scott and Brian Alexander

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