General Chapters is responsible for many critical areas in pharmaceutical quality chemical analysis, material physical properties characterization, microbiological quality, dosage forms, packaging and distribution of pharmaceutical products, pharmaceutical analysis lifecycle and scientific data quality and statistics in pharmaceutical development. These focus areas will be developing standards that are relevant in an evolving global environment. This impacts pharmaceutical development and production in all its phases and requires engagement across global regulators, industry, and other stakeholders. Chemical Analysis • Automation of analytical techniques • Spectroscopic techniques • Process analytical technology, Real time release testing • Life-cycle approach of analytical technologies • Digital applications in analytical technology • Data integrity and data governance • GC reference standard development • Impurities characterization, including inorganic, organic and mutagenic (extractables and leachables) • Risk-based approaches Dosage Forms • Quality and performance tests for all types of dosage forms • Complex products such as complex injectables, ophthalmics, topicals & transdermal, nasal & inhalation products. Materials Physical Properties Characterization • Standards and guidelines for analytical procedures for the material’s physical properties characterization and quality control, including the input and in-process materials (e.g., particles, powders, liquids, slurries) used in the manufacturing of a drug product and/or its components (excipients, drug substance, etc.) Microbiology • Rapid/Modern Microbiological Methods • Monocyte Activation Test, replacement tests for the Rabbit Pyrogen Test • In-process bioburden • Microbiological contamination control strategy • Sterility Assurance • Sterilization Packaging and Distribution • Packaging sustainability, Recycled plastic materials, Biodegradable and sustainable packaging materials • Good Distribution Practices (GDP), Temperature control management, Temperature excursion management, Temperature mapping, Distribution packaging system • Packaging suitability, Biocompatibility, Polymer chemistry, Glass quality, Extractable and Leachables Pharmaceutical Analysis Lifecycle – Data Science • Analytical Procedures Lifecycle • Chemometrics • Ongoing procedure performance verification, statistical tools for process/procedure performance monitoring (multivariate and univariate procedures) • Measurement Uncertainty and Total Analytical Error – role throughout procedure lifecycle • Analytical Instrument Qualification Statistics • Uniformity of Dosage units; Content Uniformity for Large Samples • Statistical Quality control • Sampling procedures • Analytical Procedure Equivalency • Bioassay • Multivariate data analysis