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Validation of analytical procedures – ICH Q2(R2)
The recently updated ICH Q2(R2) guidance marks a significant milestone in analytical procedure validation. Dave Elder explains why.
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Dave Elder (JPAG Member and David P Elder Consultancy)
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Pharmaceutical industry: 2023 in retrospect
In this article, Dave Elder delves deeper into some ongoing developments in topic areas highlighted in European Pharmaceutical Review (EPR) during 2023.
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COVID-19: a wakeup call?
It appears the world was unprepared for a novel coronavirus, despite historical precedents. Dave Elder provides some insight on the disease and what the pharmaceutical community is doing to tackle the pandemic.
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COVID-19: a wakeup call?
References for 'COVID-19: a wakeup call?', in European Pharmaceutical Review Issue 2 2020.
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The role of ELSIE in evolving current thinking on extractables and leachables
Extractables and Leachables Safety Information Exchange (ELSIE) has been the most influential industry group in developing guidelines for extractables and leachables. In the wake of the ICH convening a new group to develop a concept paper and business plan on their Q3E Impurity Guideline, Dave Elder discusses the strides that…
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ICH M9: biopharmaceutics classification system-based biowaivers
ICH M9 biopharmaceutics classification system-based biowaivers1 is currently at step 2b and feedback from interested parties is being evaluated.2 This guideline should reach the implementation stage (step 4) during 2020. However, industry still has concerns relating to several key areas of the guidance. Here, Dave Elder summarises these ICH M9…
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ICH Q12: Technical and regulatory considerations for pharmaceutical product lifecycle management
The International Conference on Harmonisation (ICH) is drafting guidance for product lifecycle management (ICH Q12) – currently stage 2b, which requires application of the concepts of Quality by Design (QbD) to ongoing lifecycle management and change control. Dave Elder dissects the guidance and discusses considerations for industry professionals.
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Allowable levels of excipients in drug products
References for 'Allowable levels of excipients in drug products', in European Pharmaceutical Review issue 4 2019.
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Elemental impurities testing and specification limits – ICH Q3D
The introduction of ICH Q3D (Guideline for Elemental Impurities)1 was an additional safety-based guidance for toxic impurities that complemented the existing ICH Q3C(R5) (Impurities: Guideline for residual solvents)2 and ICH M7(R1) (Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk);3 as well as the…
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Separation and purification applications for mutagenic impurities
Classically, isolation of key intermediates and the resultant active pharmaceutical ingredient (API) has formed the basis of clean up and purification strategies within the pharmaceutical industry...
