ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Seed-Lot System

A seed-lot system is a system according to which successive batches of a product are derived from the same master seed lot at a given passage level. For routine production, a working seed lot is prepared from the master seed lot. The final product is derived from the working seed lot and has not undergone more passages from the master seed lot than the vaccine shown in clinical studies to be satisfactory with respect to safety and efficacy. The origin and the passage history of the master seed lot and the working seed lot are recorded.

Publication Source: Rules and Guidance for Pharmaceutical Manufacturers and Distributors. Medicines Control Agency (MCA)

See also: Master Seed Lot Working Seed Lot

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