研发以及注册中的几个“批”的定义 - bjcanny/canny.github.io GitHub Wiki

WHO TRS 1010 Annex 10 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products

commitment batches. Production batches of an active pharmaceutical ingredient or finished pharmaceutical product for which the stability studies are initiated or completed post-approval through a commitment made in a regulatory application.

承诺批次。通过注册申请中的承诺，在批准后开始或完成稳定性研究的 API 或成品的生产批次。

pilot-scale batch. A batch of an active pharmaceutical ingredient or finished pharmaceutical product manufactured by a procedure fully representative of and simulating that to be applied to a full production-scale batch. For example, for solid oral dosage forms, a pilot scale is generally, at a minimum, one-tenth that of a full production scale or 100 000 tablets or capsules, whichever is the larger, unless otherwise adequately justified.

中试批。通过完全代表并模拟应用于整个生产规模批次的程序制造的 API 或制剂批次。例如，对于固体口服制剂，除非另有充分理由，否则中试规模通常至少为全生产规模的十分之一或 10 万片或胶囊（以较大者为准）。

primary batch. A batch of an active pharmaceutical ingredient (API) or finished pharmaceutical product (FPP) used in a stability study, from which stability data are submitted in a registration application for the purpose of establishing a retest period or shelf life, as the case may be.

申报批/注册批：用于稳定性研究的 API或制剂（FPP）批次，在注册申请中提交稳定性数据，以确定复验期或保质期（视情况而定）。

production batch. A batch of an active pharmaceutical ingredient or finished pharmaceutical product manufactured at production scale by using production equipment in a production facility as specified in the application.

生产批。使用申请中规定的生产设施中的生产设备，按生产规模生产的 API 或者制剂批次。

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Primary batch called also exhibit batch.

申报批也称为“展示批”。

engineering batch : An engineering batch is made prior to full scale cGMP batch, to finetune the process, finalizing batch production records and finalizing a process control strategy.

工程批：在完整规模的 cGMP批生产之前，先进行工程批生产，以微调工艺、最终确定批生产记录和工艺控制策略。

Biobatch：The lot of drug product formulated for purposes of pharmacokinetic evaluation in a bioavailability/bioequivalence study.

临床研究批：在生物利用度/生物等效性研究中，为药代动力学评价而配制的制剂批次。