What is meant by registration or authorisation batches?
Registration or authorisation batches are used for long-term stability studies that are later included in the marketing authorisation application for the medicinal product. They correspond as nearly as possible to the later commercial batches in the marketing phase with regard to the equipment, starting materials and manufacturing processes used.
Storage of the batches takes place in the container/closure system(s) provided later in the marketing phase. These batches are thus representative of the product that will later be available on the market.
[GMP Compliance Adviser, Chapter 14.E.5]
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