FDA issues increasing number of Form 483s for data integrity violations in 2016

Data integrity problems in pharmaceutical quality control are driving more regulatory action than ever before. Tony Harrison provides guidance on best practice for data handling at this year's Cleanroom Technology Conference

A recent report states that 79% of FDA 483 Warning Letters in 2016 cited data integrity failings. This figure shows how important an area of focus for the regulatory authorities in the US data integrity has become.

Data Integrity issues can relate to any routine or non-routine measurements or records of sampling procedures, manufacturing parameters, test or batch quality records in pharmaceuticals production. Such records, whether handwritten or instrument generated, must be made available for inspection and analysis by the authorities to show that they have not been altered or tampered with.

The integrity of data extends right through to cleanroom data collected in GMP facilities. Exactly how data integrity can have an impact on cleanroom tasks such as environmental monitoring will be the topic of a presentation by Tony Harrison, Senior Marketing Manager, Beckman Coulter Life Sciences at the Cleanroom Technology 2017 Conference in Birmingham.

Tony Harrison will highlight how the FDA’s ALCOA initiative provides guidance on best practice for data handling and how this may be applied to the pharmaceutical industry using cleanroom environmental monitoring as an example.

Tony Harrison – Senior Marketing Manager at Beckman Coulter Life Sciences

Experienced in water system TOC, conductivity and ozone analysis and cleanroom environmental monitoring as well as particle characterisation, Tony has spent the past 15 years in applied metrology for the pharmaceutical and healthcare manufacturing industries. Prior to that, he worked for companies providing process control automation solutions for manufacturing industries.

An expert in his field, he has held the Convenorship of the ISO Working Group revising ISO 14698-1 & -2 for microbial control in cleanrooms and was the UK subject matter expert to the ISO Working Group who issued the 2015 revised versions of the ISO 14644-1 & -2 documents for cleanroom classification at the heart of the aseptic manufacturing chapters of both the European GMP and the USA cGMP documents.

Tony was joint-editor on the ISPE Guide to Ozone Sanitisation of Pharmaceutical Water Systems and was also chief editor of the PHSS Best Practice Guide for Cleanroom Monitoring.

He is a well-known international speaker and has provided educational seminars on TOC, liquid particle counting, ozone sanitisation for water systems and cleanroom monitoring in UK, France, Italy, India, Malaysia, China, USA, Scandinavia, Ireland, Hungary, Switzerland, Indonesia, Belgium, Greece, Switzerland, Turkey, Egypt, Denmark, Poland, Italy and most recently South Africa and Columbia.

The Cleanroom Technology Conference will take place on 12-13 September, at the National Conference Centre, Birmingham.
For more information please visit www.cleanroomconference.com or contact Ali Badr on +44 207 193 6654 | cleanroom@hpcimedia.com.

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