EMA QWP 更新药品质量问答第 2 部分，明确进厂起始物料减少检测不应写入注册标准
EMA QWP：Reduced testing of incoming starting materials
EMA QWP 更新药品质量问答第 2 部分，明确进厂起始物料的减少检测由 GMP 覆盖，上市许可申报的注册标准不应提及减少检测。该问答适用于人用药与兽药，官方章节更新记录为 2026-05-29，并提示减少检测不应与跳批检验混淆。
该问答指出进厂起始物料的减少检测归 GMP 范畴，上市许可注册标准不应提及，需与跳批检验区分。
EMA QWP 药品质量问答，第 2 部分。
官方章节更新记录：2026-05-29。
H 表示人用药，V 表示兽药；各问答的适用范围保留在原文中。
Reduced testing of incoming starting materials
1. What information should be included in marketing authorisation dossiers regarding actual testing performed by finished product manufacturer, on receipt of any incoming starting materials?
What information should be included in marketing authorisation dossiers regarding the actual testing performed by the finished product manufacturer, on receipt of any incoming starting materials (e.g. active substances, excipients, packaging materials, etc) and before use in production of the medicinal product? H+V
Although some parameters should always be tested on receipt by the finished product manufacturer, such as identification and specific requirements for excipients with an identified risk (e.g., diethylene glycol/ethylene glycol contamination), what is actually tested on receipt is covered under good manufacturing practice [reference]. Consequently, the relevant registered specifications for incoming starting materials used by the finished product manufacturer in the marketing authorisation application should not include any reference at all to reduced testing of said materials.
Reduced testing should not be confused with skip testing (see Q&A on Skip testing).
References:
- For human medicinal products: EU GMP part I, chapter 5 (5.27 to 5.39)
- For veterinary medicinal products: Commission Implementing Regulation (EU) 2025/2091, Article 28
来源：EMA QWP 药品质量问答 · ema.europa.eu