Burgess, United Kingdom
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The original basis of Analytical Instrument Qualification 〈1058〉 was the 2004 AAPS white paper on Analytical Instrument Qualification, which focused on a risk-based approach to analytical instrument qualification (AIQ) by classifying apparatus (Group A), instruments (Group B), and computerized analytical systems (Group C) based on the laboratory's intended use (1). The definition of the intended use is key to the process because the same item could be classified in any of the three groups depending on its use. This Stimuli article proposes a new risk-based life cycle model that extends the current 〈1058〉 approaches and makes the chapter compatible with the second edition of the Good Automated Manufacturing Practice 5 Good Practice Guide (GAMP 5 GPG) for the validation of computerized systems published in late 2011.


Burgess C.,Burgess Analytical Consultancy Ltd
Pharmaceutical Technology | Year: 2014

A risk-based guard band surrounds a specification limit and is derived from the uncertainty of the reportable value of the analytical procedure, which includes the uncertainty in the reference standard. The author discusses requirements for generating a scientifically sound reportable value (or reportable result) as well as methods for calculating the associated measurement uncertainty. This aspect leads directly to the calculation of sound and defendable guard bands associated with reportable values derived from knowledge of the analytical procedure capability. Examples of this guard band approach will be given for an active ingredient assay and an impurity assay of a drug product where a reference standard is used. © 2014 Advanstar Communications Inc. All rights reserved.


McDowall R.D.,R.D. McDowall Ltd | Burgess C.,Burgess Analytical Consultancy Ltd
Spectroscopy (Santa Monica) | Year: 2013

In this column we have presented a comprehensive risk assessment process for classifying apparatus, instruments, and computerized laboratory systems used in regulated laboratories. The intention is to demonstrate clearly that an integrated approach to analytical instrument qualification and, where appropriate, computerized system validation, is more efficient than separating the two tasks. The risk assessment also ensures that laboratories qualify or validate all intended use functions in an item and aims to minimize regulatory exposure from omitting work.


Burgess C.,Burgess Analytical Consultancy Ltd | Hammond J.,Starna Scientific Ltd
Spectroscopy Europe | Year: 2010

Christopher Burgess, Burgess Analytical Consultancy Limited, discusses the advancements in the fluorescence spectrometry that is influenced by its ability to be introduced into cells, with spontaneous folding and formation of the fully fluorescent protein. The quantum dots can be made manufactured and made to fluorescence across the whole spectrum provided with the property that while the excitation wavelength remains constant, the emitted color is produced by simply changing the size of dot, which allows for the easy development multi-color assays. An ideal spectrofluorometer must contain a light source which yields a constant photon output at all wavelengths, a monochromator whose efficiency is unaffected by polarization and a detector whose response function is independent of wavelength.


Burgess C.,Burgess Analytical Consultancy Ltd | McDowall B.,R.D. McDowall Ltd
LC-GC Europe | Year: 2016

One of the common threads in the six data integrity guidance documents published to date is the need to control any blank forms used in regulated GXP laboratories. This month’s “Questions of Quality” is focused on how to interpret the regulator’s requirements for this topic. We also pose the question: Is paper the best way to record regulated data?. © 2016 Advanstar Communications Inc. All rights reserved.


Burgess C.,Burgess Analytical Consultancy Ltd | McDowall R.D.,R.D. McDowall Ltd
LC-GC Europe | Year: 2015

Primary record is a term that was defined by the MHRA (Medicines and Healthcare products Regulatory Agency, the UK drug regulator) in data integrity guidance issued in 2015. In this instalment of Questions of Quality we explore what this term means in practice, and compare it with raw data in the European Union Good Manufacturing Practices (EU GMPs) and complete data in US Food and Drug Administration (FDA) GMPs. Why can’t we have harmonization of terms? © 2015 Advanstar Communications Inc. All rights reserved.


Burgess C.,Burgess Analytical Consultancy Ltd | Hammond J.P.,Starna Scientific Ltd.
Spectroscopy Europe | Year: 2015

The General Chapters Expert Committee of the US continues to review collections of chapters in a holistic approach in order to align concepts and content to ensure consistency. These revisions are intended to ensure that the scientific expectations defined in the chapters are aligned with current best practices to ensure suitability for use when the appropriate measurements are executed. The purpose of spectroscopic General Chapters is to provide the basis for establishing that an instrument or system is suitable for use in a USP monograph. This suitability for use is related to the technical performance specification of the instrument or system and represents a minimum standard.

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