tteeonSpecificationsforPharmaceuticalPreparations.Twenty-se condreport.Geneva,WorldHealthOrganization,1992Annex1(WHO TechnicalReportSeries,No.823).2.Validationofanalyticalp roceduresusedintheexaminationofpharmaceuticalmaterials.In :WHOExpertCommitteeonSpecificationsforPharmaceuticalPrepa rations.Thirty-secondreport.Geneva...
A very detailed Standard already exists for the manufacture and distribution of pharmaceutical excipients. Within the framework of the ExcipactTMprogramme, which was introduced at the beginning of this year, the IPEC has published a document entitled "Certification Standards for Pharmaceutical Excipient S...
10.6. Reference standards from reputable sources (WHO or national standards) should be used, if available; otherwise the reference substance(s) for the active ingredient(s) should be prepared, tested and released as reference material(s) by the producer of the investigational pharmaceutical product,...
10.6. Reference standards from reputablesources (WHO or national standards) should be used, if available; otherwise thereference substance(s) for the active ingredient(s) should be prepared, testedand released as reference material(s) by the producer of the investigationalpharmaceutical product, or b...
3.1. The recommendations in this guidelineare applicable to investigational products for human and veterinary use. 本指南的建议适用于人用和兽用临床试验药品。 3.2. Although the focus is on medicinal(pharmaceutical) products, some of...
Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles 附录2 WHO药品GMP:主要原则 Introduction引言 General considerations总则 Glossary术语 Quality management in the medicines industry: philosophy and essential elements 制药企业的质量管理:GMP 理念和基本元素 1. Pharmaceutical quality...
In addition, the appendix includes some industry best practices and standards to help companies improve their production quality and efficiency. 第二篇示例: 中国GMP附录英文版 Chinese Good Manufacturing Practice (GMP) Appendix Introduction China's pharmaceutical industry has been growing rapidly in recent...
GMP standards will support national pharmaceutical industryIf a company has GMP certificate, it means that it is manufacturing medicines of the same quality as Austrian, German or French pharmaceutical manufacturers: Suren Krmoyanarmenpress.am
术语 Q7a GMP Guidance for APIs Q7a 原料药的 GMP 指南 INTRODUCTION 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. It is also intended ...
3.1. The recommendations in this guidelineare applicable to investigational products for human and veterinary use. 本指南的建议适用于人用和兽用临床试验药品。 3.2. Although the focus is on medicinal(pharmaceutical) products, some of the principles may be applied to otherinvestigational products. ...