ICH Guidelines

ICH Guidelines

ICH Guideline PDF provides recommendations on stability testing protocols including temperature, humidity, and trial duration for Climatic Zone I and II. Furthermore, the revised document takes into account the requirements for stability testing in Climatic Zones III and IV in order to minimize the different storage conditions for the submission of a global dossier.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. ICH Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. In Step 4 of the Process, the final draft is recommended for adoption by the regulatory bodies of the European Union, Japan, and the USA.

ICH Guidelines

1. Quality Guidelines: Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing, and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management. To check the Quality Guidelines in PDF
2. Safety Guidelines: ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years.
3. Efficacy Guidelines: The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better-targeted medicines.
4. Multidisciplinary Guidelines: Those are the cross-cutting topics that do not fit uniquely into one of the Quality, Safety, and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD), and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).

You can download the ICH Guidelines PDF using the link given below.