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European Pharmaceutical Contractor

Unfamiliar Grounds

Audit preparation can seem like a daunting task, especially when the subject area is complex or unfamiliar. It is often a balancing act between competing priorities and expectations, as well as being vigilant that the audit remains a quality assurance exercise (i.e., scratching the subject surface and verifying compliance through information sampling).

Know the Audit Scope

Very rarely are auditors in a position to attend an audit with little preparation. To do so would only set the audit up for disaster as essential audit objectives may not be met, with time spent on activities that were not a priority for the audit outcome.

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About the author

Iain Pulley is a GCP auditor with over 12 years of experience auditing both global pharmaceutical organisations and clinical trials. With a BSc (Hons) in Product Design, he is passionately process-orientated and places a strong emphasis on ensuring quality management systems add value to achieve right-first-time results. Iain has also successfully assisted and coached various organisations in preparation for receiving regulatory authority inspections.
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News and Press Releases

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CPI, a UK-based technology innovation centre and a founding member of the High Value Manufacturing Catapult, announced today that it will host an event in Darlington, UK on 26 June 2019 to disseminate the results of the £11.2M BioStreamline project to optimise the development of novel therapeutics. During the event, the project partners — Lonza Biologics, UCB Celltech, Sphere Fluidics, Horizon Discovery Group plc (Horizon), Alcyomics Ltd and CPI — will showcase the results and discuss the potential impact on overcoming some of the most significant shortcomings of the biologics supply chain.
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