This guidance revises and replaces the guidance Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. This revision changes the ICH codification from Q7A to Q7.

2023年11月1日 · ICH指导原则由国家药品监督管理局药品审评中心发布，提供药品研发和审评的指导。

This document provides guidance on the good manufacturing practice for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It also aims to help ensure that APIs meet the requirements for quality and purity.

2019年6月26日 · EC_Q7a 5 Q7a GMP Guidance for APIs Q7a 原料药的GMP 指南 1. INTRODUCTION 1. 简介 1.1 Objective 1.1 目的 This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.

* ich 指南 q 5a “生物制品的质量：从人体或动物源细胞得到的生物制品的病毒安全性评估”中描述的生物制品的病毒安全性。 18.17 必要时，应证明培养基、宿主细胞蛋白、其它与工艺有关的杂质、与产品有关的杂质和污染物的去除效果。

本指南旨为在适当的质量管理体系下为活性药物成分（APIs）的生产提供关于药品生产质量管理规范 (GMP)方面的指导。 本指南也有助于确保APIs达到其预期的质量和纯度。 本指南中的“生产”一词被定义为包括APIs的物料接受、生产、包装、再包装、贴签，再贴签、质量控制、放行、贮存和分发等在内的所有操作，以及相关的控制。 本指南中的术语“应当”指期望使用的建议，除非不合适或可提供至少能得到同等程度的质量保证的另一种方法。 本指南中的“现行药品生产质量管理 …

ICH HARMONISED TRIPARTITE GUIDELINE GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS Q7 Current Step 4 version dated 10 November 2000 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in …

INTRODUCTION 1.1 Objective This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.

ICH Q7 expects dedicated production areas for highly sensitizing materials such as penicillins and cephalosporins because of the patient risk (e.g., anaphylactic shock to

2020年7月2日 · EC_Q7a 7 point at which production of the API begins. For synthetic processes, this is known as the point at which API starting materials are entered into the process. For other processes (e.g., fermentation, extraction, purification), this rationale should be established on a case-by-case basis. Table 1 gives guidance on the point at which the ...