Authors
Markus Blümel, Sebastian Dreis-Kühne, Wiebke Holkenjans, Matthias Jochum, Sabine Möcklinghoff, Gerd Benirschke, Markus W Wendeler, Jochen Felix Kepert, Christian Korn, Thomas Kramer, Anette Partheil, Michael Finkam, Harold Taylor, Peter Woitke, Stefanie Hauck, Muriel Cordon Federspiel, Stephan Brombacher
Published in
Journal of pharmaceutical sciences. Pages 104456. Aug 11, 2026. Epub Aug 11, 2026.
Abstract
Analytical development experts from nine pharmaceutical companies share their collective experience and perspective on the minimum expectations when establishing scientifically sound practices (SSP) during technical development of pharmaceuticals; some companies use the equivalent expression 'good scientific practices'. The authors describe the SSP framework as a comprehensive set of best practices and recommendations for analytical development activities focused on a flexible and "fit for purpose" approach supporting the different development phases as well as post commercialization life-cycle management. It covers scientific and technical activities not performed under current Good Manufacturing Practices (cGMP) yet resulting in data or information that may become regulatorily relevant by submitting to health authorities, particularly in CMC documentation during clinical development, NDA/BLA/MAA filings or post-approval changes. These activities include for example analytical development activities related to product characterization, comparability assessments, forced degradation studies, cell line development, manufacturing process development, (pre-)formulation studies, device development, or investigations related to cGMP activities. Data requires good documentation practice ensuring that all records are accurate, complete, legible, and traceable, supporting data integrity and regulatory compliance in scientific and clinical work. Analytical developmental activities significantly impact the control of manufacturing processes and overall control strategies. They provide rationales and justifications for controls, such as specifications, that are subsequently maintained under cGMP. Therefore, these activities require appropriate scientific scrutiny to ensure high data quality. This ensures continual improvement across the entire product lifecycle by promoting a science- and risk-based approach during each lifecycle stage. As described in ICH Q10, such an approach fosters an integrated and effective pharmaceutical quality system, enhances innovation, and connects development and manufacturing activities through quality risk management.
PMID:
42580526
Bibliographic data and abstract were imported from PubMed on 12 Aug 2026.
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