BioQC Articles | Latest Insights in Biopharmaceutical Quality

ICH Q14: Guideline Overview for Analytical Procedure Lifecycle Management

AdvertisementThe ICH Q14 guideline, formally part of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), represents a step forward in ensuring that analytical methods for pharmaceuticals are scientifically...

Read Article | Full text | Obtain a clear overview of the ICH Q14 guideline and understand how its lifecycle management framework integrates method development, validation, and continual improvement into a cohesive, science-based approach.

Analytical Method Validation: Expert Panel Discussion on ICH Q2 Revision 2 Practical Implementation

by BioQC Summary

Advertisement This summary accompanies a recent expert forum discussion organised by BioQC. We appreciate the panellists’ time and expertise. The views expressed by the panellists are their personal interpretations and do not represent the positions of their...

Panel Q&A | PDF download | Gain clarity on the distinction between instrument response linearity and whole-procedure linearity, and explore how adopting response function terminology can improve consistency and reduce confusion across different calibration model types.

Analytical Method Validation: Expert Panel Discussion on ICH Q2 Revision 2

by BioQC Summary

Advertisement This summary accompanies a recent expert forum discussion organised by BioQC. We appreciate the panellists’ time and expertise. The views expressed by the panellists are their personal interpretations and do not represent the positions of their...

Panel Q&A | PDF download | Explore how prior knowledge and development phase data can be leveraged within a validation framework, and learn what justification is required to implement this lifecycle approach effectively across your organisation.

Quality Control in the (Bio)Pharmaceutical Industry: Safeguarding Medicines for Global Health

by BioQC Article

AdvertisementIn the pharmaceutical industry, the stakes for producing high-quality products are unparalleled. Medicines, whether traditional small molecules or advanced biologics, can save lives, prevent diseases, and improve quality of life. However, rigorous Quality...

Read Industry Primer | Full text | Understand why rigorous quality control is essential across the pharmaceutical product lifecycle, and explore how QC approaches differ between small molecules, biologics, and advanced therapies such as cell and gene treatments.

Specification Setting for Biopharmaceuticals: Expert Panel Discussion on Best Practices

by BioQC Summary

Advertisement This summary accompanies a recent expert forum discussion organised by BioQC. We appreciate the panellists’ time and expertise. The views expressed by the panellists are their personal interpretations and do not represent the positions of their...

Panel Q&A | PDF download | Understand how specification setting for biopharmaceuticals requires multidisciplinary input, and learn how release and shelf life specifications are determined and differentiated based on product stability data and process capability.

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ICH Q14 Implementation: Expert Panel Discussion on Analytical Method Development

by BioQC Summary

Advertisement This summary accompanies a recent expert forum discussion organised by BioQC. We appreciate the panellists’ time and expertise. The views expressed by the panellists are their personal interpretations and do not represent the positions of their...

Panel Q&A | PDF download | Explore how multivariate optimisation tools such as risk assessment, Design of Experiments, and MODR studies can be applied modularly to strengthen method development and inform validation, without replacing fundamental analytical understanding.

Analytical Target Profiles and Method Development in ICH Q14: A Panel Discussion on Best Practices

by BioQC Summary

Advertisement This summary accompanies a recent expert forum discussion organised by BioQC. We appreciate the panellists’ time and expertise. The views expressed by the panellists are their personal interpretations and do not represent the positions of their...

Panel Q&A | PDF download | Learn how and when ATPs can be appropriately revised during method development, and explore the bidirectional review process needed to ensure any changes remain scientifically justified and aligned with the overall control strategy.