Using the Analytical Target Profile to Drive the Analytical Method Lifecycle

Jackson, Patrick; Borman, Phil J.; Campa, Cristiana; Chatfield, Marion J.; Godfrey, M. C.; Hamilton, Peter; Hoyer, W.; Norelli, Francesco; Orr, Rachel; Schofield, Tim

doi:10.1021/acs.analchem.8b04596

Cited by 72 publications

(41 citation statements)

References 14 publications

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“…-The key component and the first step of the AQbD is to determine the analytical target profile (ATP) (33), the aim of the devel-oped analytical method (34) without identifying the method development steps and the method itself. An up-to-date definition of ATP was formulated by Jackson et al (35) stipulating that "ATP, in a similar fashion to the quality target product profile (QTPP), prospectively summarizes the requirements associated with a measurement on a quality attribute which needs to be met by an analytical procedure and is used to define and assess the fitness of an analytical procedure in the development phase and during all changes across the analytical lifecycle".…”

Section: Quality-by-design In the Development Of Analytical Methods And Pharmaceutical Manufacturingmentioning

confidence: 99%

Quality-by-design in pharmaceutical development: From current perspectives to practical applications

et al. 2021

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Current pharmaceutical research directions tend to follow a systematic approach in the field of applied research and development. The concept of quality-by-design (QbD) has been the focus of the current progress of pharmaceutical sciences. It is based on, but not limited, to risk assessment, design of experiments and other computational methods and process analytical technology. These tools offer a well-organized methodology, both to identify and analyse the hazards that should be handled as critical, and are therefore applicable in the control strategy. Once implemented, the QbD approach will augment the comprehension of experts concerning the developed analytical technique or manufacturing process. The main activities are oriented towards the identification of the quality target product profiles, along with the critical quality attributes, the risk management of these and their analysis through in silico aided methods. This review aims to offer an overview of the current standpoints and general applications of QbD methods in pharmaceutical development.

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Section: Quality-by-design In the Development Of Analytical Methods And Pharmaceutical Manufacturingmentioning

confidence: 99%

Quality-by-design in pharmaceutical development: From current perspectives to practical applications

et al. 2021

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“…microscopic (blend homogeneity) vs macroscopic (granule density, granule size/distribution) are defined. This can be summarised in an Analytical Target Profile (Jackson et al, 2019) to prospectively define the requirements of the method. A key element to consider, which can impact the point of testing, is whether the control strategy is intended for monitoring only or real-time feedback control is required (Yu et al, 2014).…”

Section: Rtrt Development Workflowmentioning

confidence: 99%

Review of real-time release testing of pharmaceutical tablets: State-of-the art, challenges and future perspective

Markl

Warman

Dumarey

et al. 2020

International Journal of Pharmaceutics

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In the last decade significant advances have been made in process analytical technologies and digital manufacturing of pharmaceutical oral solid dosage forms leading to enhanced product knowledge and process understanding. These developments provide an excellent platform for realising real-time release testing (RTRT) to eliminate all, or certain, off-line end product tests assuring that the drug product is of intended quality. This review article presents the state of the art, an RTRT development workflow as well as challenges and opportunities of RTRT in batch and continuous manufacturing of pharmaceutical tablets. Critical quality attributes, regulatory aspects and the scientific basis of enabling technologies and models for RTRT are discussed and a systematic development workflow for the robust design of an RTRT environment is presented. This includes the discussion of key considerations for the identification of the critical quality attributes and points of testing as well as the development of the sampling strategy, a hard and/or soft sensor approach and operational procedures. The final sections present two RTRT use cases in an industrial setting as well as critically discuss challenges and provide a future perspective of RTRT.

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“…The limits presented in the ATP show a combined accuracy and precision uncertainty of ±5% with 95% probability. Also, these accuracy and precision limits are commonly accepted by the pharmaceutical regulatory agencies [25].…”

Section: Analytical Target Profilementioning

confidence: 99%

“…These requirements are identified in the initial steps of method development and are summarised by the analytical target profile (ATP). Examples of ATPs can be found in a recent publication by Jackson et al where they proposed a harmonised approach to the use of the ATP concept [25]. The ATP is analogous to the quality target product profile (QTPP) and summarises the performance requirements associated with a measurement (e.g., accuracy and precision) on a quality attribute which needs to be met by an analytical procedure.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of an in-line API Quantification Method Using AQbD Principles Based on UV-Vis Spectroscopy to Monitor and Optimise Continuous Hot Melt Extrusion Process

et al. 2020

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A key principle of developing a new medicine is that quality should be built in, with a thorough understanding of the product and the manufacturing process supported by appropriate process controls. Quality by design principles that have been established for the development of drug products/substances can equally be applied to the development of analytical procedures. This paper presents the development and validation of a quantitative method to predict the concentration of piroxicam in Kollidon® VA 64 during hot melt extrusion using analytical quality by design principles. An analytical target profile was established for the piroxicam content and a novel in-line analytical procedure was developed using predictive models based on UV-Vis absorbance spectra collected during hot melt extrusion. Risks that impact the ability of the analytical procedure to measure piroxicam consistently were assessed using failure mode and effect analysis. The critical analytical attributes measured were colour (L* lightness, b* yellow to blue colour parameters—in-process critical quality attributes) that are linked to the ability to measure the API content and transmittance. The method validation was based on the accuracy profile strategy and ICH Q2(R1) validation criteria. The accuracy profile obtained with two validation sets showed that the 95% β-expectation tolerance limits for all piroxicam concentration levels analysed were within the combined trueness and precision acceptance limits set at ±5%. The method robustness was tested by evaluating the effects of screw speed (150–250 rpm) and feed rate (5–9 g/min) on piroxicam content around 15% w/w. In-line UV-Vis spectroscopy was shown to be a robust and practical PAT tool for monitoring the piroxicam content, a critical quality attribute in a pharmaceutical HME process.

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Using the Analytical Target Profile to Drive the Analytical Method Lifecycle

Cited by 72 publications

References 14 publications

Quality-by-design in pharmaceutical development: From current perspectives to practical applications

Quality-by-design in pharmaceutical development: From current perspectives to practical applications

Review of real-time release testing of pharmaceutical tablets: State-of-the art, challenges and future perspective

Development and Validation of an in-line API Quantification Method Using AQbD Principles Based on UV-Vis Spectroscopy to Monitor and Optimise Continuous Hot Melt Extrusion Process

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