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Shipping Validation Requirements - Guidelines

While CFR21 Section 211 sets quality standards, ICH, GDP, WHO, USP, and national authorities provide regulatory guidelines for maintaining quality during pharmaceutical transportation.

Key Regulatory References:

  1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH):
    • ICH Q1A(R2): Stability Testing
    • ICH Q1D: Bracketing and Matrixing Designs
    • ICH Q1E: Evaluation for Stability Data
  2. Good Distribution Practice (GDP):
    • EU GDP Guidelines
    • U.S. FDA's Guidance - Distributing Publications
  3. World Health Organization (WHO):
    • WHO Good Distribution Practices
  4. U.S. Pharmacopeia (USP):
    • USP Chapter <1079>: Good Storage and Shipping Practices
  5. National Regulatory Authorities:
    • Each country may have its own regulatory requirements and guidelines related to the distribution and transportation of pharmaceutical products. Pharmaceutical companies are typically required to comply with the regulations of the countries in which their products are distributed.