ICH Regulations

sort by Title sort by   Date    Download  Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products The objective of this guideline is to provide harmonised guidance on the application of bracketing and matrixing for stability studies conducted in accordance with principles outlined in the ICH Q1A Harmonised Tripartite guideline covering Stability Testing of New Drug Substances and Products (hereafter referred to as the parent guideline).  2002-02-07    PDF file (335 KB)  Impurities in New Drug Substances This document is intended to provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state. ICH  2002-02-07    PDF file (256 KB)  Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 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  2000-11-10    PDF file (267 KB)  Stability Testing of New Drug Substances and Products The guideline addresses the information to be submitted in registration applications for new molecular entities and associated drug products. ICH  2000-11-08    PDF file (221 KB)  Impurities: Residual Solvents (Maintenance) PDE for Tetrahydrofuran Concensus about new toxicity data for the solvent tetrahydrofuran (THF). ICH  2000-07-20    PDF file (12 KB)  Impurities: Residual Solvents (maintenance) PDE for N-Methylpyrrolidone (NMP) The document contains an analysis of an appropriate and more sensitive study from which to calculate a new PDE. ICH  2000-07-20    PDF file (12 KB)  Impurities in New Drug Products This document provides guidance recommendations for registration or marketing applications for marketing on the content and qualification of impurities in new Drug Products produced from chemically synthesised new drug substances not previously registered in a region or member state. ICH  1999-10-07    PDF file (208 KB)  Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances It provides guidance on the setting and justification of acceptance criteria and the selection of test procedures for new drug substances of synthetic chemical origin, and new drug products produced from them, which have not been registered previously in the United States, the European Union, or Japan. ICH  1999-10-06    PDF file (69 KB)  Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products This guidance document provides general principles on the setting and justification, to the extent possible, of a uniform set of international specifications for biotechnological and biological products to support new marketing applications. ICH  1999-03-10    PDF file (57 KB)  Impurities: Guideline for Residual Solvents The objective of this guideline is to recommend acceptable levels of residual solvents in pharmaceuticals for the safety of the patient. ICH  1997-07-17    PDF file (55 KB)  Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products The guideline provides broad guidance on appropriate standards for the derivation of human and animal cell lines and microbial cells to be used to prepare biotechnological/biological products defined in Section 1.3, Scope, and for the preparation and characterisation of cell banks to be used for production. ICH  1997-07-16    PDF file (45 KB)  Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin This document is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin (i.e., mammalian, avian, insect) and outlines data that should be submitted in the marketing application/registration package. ICH  1997-03-05    PDF file (87 KB)  Stability Testing: Photostability Testing of New Drug Substances and Products The guideline primarily addresses the generation of photostability information for submission in Registration Applications for new molecular entities and associated drug products. ICH  1996-11-06    PDF file (36 KB)  Stability Testing: Requirements for New Dosage Forms This document is an annex to the ICH parent stability guideline and addresses recommendations on what should be submitted regarding stability of new dosage forms by the owner of the original application, after the original submission for new drug substances and products. ICH  1996-06-11    PDF file (10 KB)  Validation of Analytical Procedures: Methodology This document is complementary to the parent document which presents a discussion of the characteristics that should be considered during the validation of analytical procedures. Its purpose is to provide some guidance and recommendations on how to consider the various validation characteristics for each analytical procedure. ICH  1996-06-11    PDF file (30 KB)  Guideline for Good Clinical Practice The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.  1996-05-01    PDF file (126 KB)  Quality fast Biotechnological Products: Stability Testing of Biotechnological/Biological Products The guidance stated in this annex applies to well-characterised proteins and polypeptides, their derivatives and products of which they are components, and which are isolated from tissues, body fluids, cell cultures, or produced using rDNA technology. ICH  1995-11-30    PDF file (30 KB)  Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of R-DNA Derived Protein Products This document provides guidance on the characterisation of the expression construct for the production of recombinant DNA protein products in eukaryotic and prokaryotic cells. ICH  1995-11-30    PDF file (20 KB)  Text on Validation of Analitical Procedures This document presents a discussion of the characteristics for consideration during the validation of the analytical procedures included as part of registration applications submitted within the EC, Japan and USA. ICH  1994-10-27    PDF file (19 KB)

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