FDA & ICH: Regulations And Standards For Temperature-Controlled Supply Chains

In this application note we look at the FDA regulations and ICH guidelines that address supply chain management for temperature-controlled pharmaceutical and biotechnical products, including:

• ICH Guidance for Industry Q1A(R2) Stability Testing of New Drug Substances and Products
• ICH Harmonised Tripartite Guidelines Q6A and Q6B(Test Procedures and Acceptance Criteria for New Drugs and New Biotechnology
• FDA CFR Title 21 203.32, 203.36, 211.150
• FDA 483 observations on cold chain applications with suggested deviation offsets