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Analytical quality by design (AQbD) in the ICHQ14 guidelines for analytical procedure development

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Abstract

Analytical quality by design (AQbD) is one of the risk-based approach used to develop robust analytical method in compliance with regulatory requirements. The concept of AQbD was recently established in the literature and has proven advantages in the pharma industries. Despite the differential view on AQbD, the International Council for Harmonization (ICH) has released the ICHQ14 document for analytical procedure development. Notably, the enhanced approach of the ICHQ14 document mimics AQbD workflows in analytical procedure development. Among ICHQ14 recommendations, the need for knowledge assessment, multivariate models for proven acceptable range (PARs) as method operable region, sample suitability assessment in robustness, and real-time release testing with product critical quality attribute specifications  as the challenging components for pharmaceutical industries. In addition, the integration of ICHQ14 with other ICH documents like ICH Q6A/6B, ICHQ8, ICHQ9, ICHQ10, ICHQ11, and ICHQ12 are well defined in the document. Thus, the revised ICHQ2 (R2) guideline has defined the validation procedure with integration to ICHQ14 documents.

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(Source: ICH Q14 Step 2 draft document; p.10 (illustration with little modification)

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Acknowledgements

The authors appreciate international council for harmonization (ICH) and its document ICHQ14 which provided a basis for developing this review and the new illustrations have been drawn for easy understanding of professionals.

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Authors and Affiliations

  1. Department of Pharmaceutical Analysis, National Institue of Pharmaceutical Education and Research, Hajipur, Bihar, 844102, India

    Kiranmayi Sathuluri, RamyaSri Bakam, Riya Jain, Aishwarya Dande, Rahul Gajbhiye, V. Ravichandiran & Ramalingam Peraman

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Contributions

Ramalingam Peraman: Study conception, design, supervision and analysis of manuscript, approved final version of the paper including references Sathuluri Kiranmayi: Collection of data, sequence alignment and drafting of manuscript, editing of manuscript, Ramyasri: Drafting of manuscript Riya Jain: Drafting of manuscript, Dande Aishwarya: alignment and drafting of manuscript, analysis of manuscript, Rahul sir: analysis of manuscript, Edited and approved final version of the paper including references, Ravichandiran: analysis of manuscript, Edited and approved final version of the paper including references.

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Correspondence to Ramalingam Peraman.

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Sathuluri, K., Bakam, R., Jain, R. et al. Analytical quality by design (AQbD) in the ICHQ14 guidelines for analytical procedure development. Accred Qual Assur (2024). https://doi.org/10.1007/s00769-024-01587-w

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