FDA & ICH: Regulations and Standards for Temperature-Controlled Supply Chains
The two greatest risks in pharmaceutical and biotechnology supply chains are the risk of product becoming adulterated during transport and the risk of non-compliance with federal regulations, guidelines and standards. After that the greatest concern of manufacturers and distributors is cost containment in an increasingly globalized, increasingly complex supply chain.
Two organizations that carry significant regulatory weight are the combined forces of the US Food and Drug Administration (FDA) and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).The FDA co-founded the ICH with the European Community in 1990 with the goal of creating a globally harmonized approach to the understanding and application of technical guidelines for drug manufacturers. The outcome of harmonisation was to decrease unnecessary replication of costly regulatory processes, thereby promoting more efficient manufacturing, processing and distribution methods for regulated products on a global scale.
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