GTDP
Good Trade and Distribution Practices for Pharmaceutical Starting Materials
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The WHO discipline governing the trade, brokering, and distribution of pharmaceutical starting materials — active ingredients and excipients — between manufacturer and user, addressing traceability, storage and transport conditions, and prevention of substitution, adulteration, or diversion of materials that have not yet entered finished-product manufacturing.
GTDP addresses a gap that finished-product distribution guidance does not fully cover: the chain of custody for raw active ingredients and excipients as they move from an API manufacturer, potentially through one or more traders or brokers, to the finished-dosage-form manufacturer that will use them.
Because starting materials at this stage may not yet carry finished-product-level documentation or tamper-evident packaging, GTDP focuses heavily on traceability — maintaining an unbroken paper trail of origin, each intermediate handler, and storage/transport conditions — as the primary defense against counterfeit or substandard materials entering the legitimate supply chain.
GTDP is particularly relevant where a starting material passes through a broker or repackager rather than moving directly from manufacturer to user, since each additional intermediary is a point where substitution or contamination could occur without adequate controls.
- —Covers the trade/broker chain for starting materials, before finished-product manufacture
- —Focuses on traceability and unbroken chain of custody as the primary control
- —Addresses risk of substitution, adulteration, or diversion of starting materials
- —Particularly relevant when brokers or repackagers sit between manufacturer and user
WHO Technical Report Series 917 (2003), Annex 2 — Good Trade and Distribution Practices for Pharmaceutical Starting Materials
Frequently asked questions
What does GTDP stand for?
GTDP stands for Good Trade and Distribution Practices for Pharmaceutical Starting Materials.
What is GTDP?
The WHO discipline governing the trade, brokering, and distribution of pharmaceutical starting materials — active ingredients and excipients — between manufacturer and user, addressing traceability, storage and transport conditions, and prevention of substitution, adulteration, or diversion of materials that have not yet entered finished-product manufacturing.
Which regulations cover GTDP?
WHO Technical Report Series 917 (2003), Annex 2 — Good Trade and Distribution Practices for Pharmaceutical Starting Materials