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 …

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...

什么是原料药 Active Pharmaceutical Ingredient？ ICH Q7A 的定义： 英文直译：活性药用成分，缩写：API. 旨在用于药品制造中的任何一种物质或物质的混合物，而且在用于制药时，成为 …

GMP principles as 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 …

活性药物成份（api）（或原料药） 任何旨在供生产一种药物（医疗用品）制剂，并作为其活性成份的物质或混合物。这类物质旨在疾病的诊断，治疗、缓减，处置或预防以及影响人体的结构 …

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 …

The ICH Q7 guideline provides details of Good Manufacturing Practice (GMP) for Active Pharmaceutical Ingredients (API). It is a guideline adopted globally for applying GMP to APIs …

APIC is the forum of producers of APIs and API intermediates in Europe. APIC’s focus is on worldwide Quality, Good Manufacturing Practice (GMP) and Regulatory matters relating to …

When a material is classified as an API in the region or country in which it is manufactured or used in a drug product, it should be manufactured according to this Guide. This Guide applies …

This webinar will cover ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (API). Attendees will gain a deeper understanding of the importance of GMPs for …