Ich q1a guideline

COLD CHAIN COMPLIANCE FDA & ICH: Regulations and …

And other ICH sponsors: Health Canada, the European Free Trade Area (EFTA), and the World Health Organization 2 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)

Current Practices in Shelf Life Estimation

• ICH Guideline Q1A defines “Shelf Life (also referred to as expiration dating period)” as “The shelf life for a pharmaceutical product is the maximum time at which a stability limiting characteristic stays within acceptance criteria. ” • Also in Q1A, “Specification Shelf Life” is defined as

  Guidelines, Ich q1a guideline