In this guidance, the term manufacturing is defined to include all operations of receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control, release, storage...

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.

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 …

In this Guide “manufacturing” is defined to include all operations of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release, storage and distribution of APIs and the related controls.

ICH Official web site : ICH

Since the ICH Q7 guidance was finalized, experience with implementing the guidance worldwide has given rise to requests for clarification of uncertainties due to the interpretation of certain sections. This Question and Answer (Q&A) document is intended to respond to those requests.

2017年6月4日 · 本文件适用于通过化学合成、提取、细胞培养/发酵，通过从自然资源回收，或通过这些 工艺的结合而得到的原料药。 通过细胞培养/发酵生产的原料药的特殊指南则在第 18 章论 述。 本指南不包括所有疫苗、完整细胞、全血和血浆、全血和血浆的衍生物 (血浆成分)和基因 治 …

采用细胞培养/ 发酵工艺生产原料药的特定要求。本指南不适用于疫苗、 全细胞、 全血和血浆、 血�. 和血浆制品( 血浆提取物)、基因治疗的 原料药。但本. 南涵盖由血液或血浆作为原材料生产 …

described in ICH Q7 should be applied regardless which approach is taken in pharmaceutical development and manufacturing. ICH Q7 also describes principles of GMPs to be applied in the manufacture of APIs for use in clinical trials (Section 19) and for APIs manufactured by cell culture/fermentation (Section 18).

2020年4月14日 · 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 ...