2020–2025 General Chapters - Physical Analysis Expert Committee Work Plan

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Focus Areas

  • Standards and guidelines for analytical procedures for the material’s physical properties characterization, including input and in-process materials (e.g., particles, powders, liquids, slurries) used in the manufacturing of drug product and/or its components (excipients, drug substance, etc.). 

Expert Committee Charge

  • The General Chapters – Physical Analysis Expert Committee is responsible for developing new and revising existing general chapters related to physical analysis (e.g., measurement of rheological parameters, phase transitions, non-specific inorganic impurities, particle size and shape measurement techniques (e.g., scattering techniques and X-Ray diffraction techniques)).

Key Issues

  • Develop new and update existing general chapters for input and in-process materials property characterization techniques used in designing, controlling and maintaining of manufacturing process (including pharmaceutical continuous manufacturing).
  • Develop new and update existing general chapters for the techniques that support process analytical technology for on-line and in-line measurements of material properties of in-process materials.
  • Modernize and harmonize particle size characterization (e.g. by analytical methodologies base on scattering phenomena such are small angle X-ray scattering, small angle light scattering, dynamic light scattering, etc.)
  • Modernize and harmonize instrumental measurement of color 
  • Continue efforts for the implementation of the new procedural general chapters <922> Water Activity and <915> Consistency of Semisolids in applicable monographs 
  • Continue the development of new informational chapters concerning physical properties characterization, for example <1236> on solubility measurement and <1149> on physical stability
  • Continue efforts for the implementation of general chapters related to continuous manufacturing process
  • Maintain physical characterization general chapters up to date by continuous review of scientific advances and respective emerging instrumental technologies
  • Consider adding new public standards for guidelines and techniques in areas within the scope of this Expert Committee (e.g., contact angle of solids and wettability, critical micelle concentration, surface tension of liquids, sedimentation, creaming, resuspendability)

Associated Expert Bodies

Subcommittees 

  • Powders
  • Particles
  • Crystals/Microscopy
  • Rheology
  • Solutions

Joint Subcommittees

  • Physical Stability-lead (with Dosage Forms, Packaging and Distribution, and Biologics General Chapters Expert Committees)
  • Osmolality and Osmolarity-lead (with Dosage Forms Expert Committee)
  • Water Activity-lead (with Microbiology and Dietary Supplements-Non Botanical Expert Committees)
  • Solubility Measurement-lead (with Veterinary Products Expert Panel)
  • Analytical Methodologies based on Light Scattering Phenomena (with Chemical Analysis Expert Committee)
  • Quality Standards for Pharmaceutical Continuous Manufacturing (with Chemical Analysis Expert Committee)
  • Nanotechnology (with Dosage Forms Expert Committee)

Working Groups

  • Image Analysis of Particles
  • Color and Achromicity

Standards Development

The latest ballot results can be found here (results can be filtered by particular ECs).

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