Regulatory Framework

Key Bodies & Standards 

  • FDA (21 CFR 210, 211, 600, 820): Current Good Manufacturing Practice regulations for pharmaceuticals, biologics, and devices.
  • USP <1231>: Guidance for water systems in pharmaceutical applications.
  • USP <643>: TOC testing for pharmaceutical water.
  • USP <467>: Residual solvent limits and testing in drug products.
  • USP <232>: Limits for elemental impurities in pharmaceutical products.
  • EP 2.5.12: Method for sulfur dioxide content in medicinal gases.
  • EP 2.6.12: Microbiological testing for non-sterile products.
  • EP 2.4.4: Microbial testing requirements for water.
  • JP General Tests: Japanese pharmacopoeia tests for gases and utilities.
  • PDA TR-7: Integrity testing of sterilizing gas filters.
  • PDA TR-13: Environmental monitoring program design and execution.
  • PDA TR-40: Guidance on gas sterilization process validation.
  • ICH Q3C: Harmonized guideline for residual solvent impurities.
  • ICH Q7: GMP standards for active pharmaceutical ingredients.
  • ISO 8573-1: Standards for compressed air quality classes.
  • ISO 14644: Cleanroom classification and monitoring standards.