ICH Guidelines|Pharmaceutical

Full form ICH Guidelines is The International Council for Harmonization. it is Requirements for Pharmaceuticals for Human Use (ICH).

Aims of ICH is provide uniform standards for technical requirements for pharmaceuticals for human use. They are developed by regulatory and pharma industry authorities. The purpose of ICH guidelines is to ensure safe, effective and high-quality medicines are developed and registered efficiently.

The ICH topics are divided into the four categories below and ICH topic codes are assigned according to these categories.

Quality Guidelines.

Safety Guidelines.

Efficacy Guidelines.

Multidisciplinary Guidelines.

Quality Guidelines.

Here cover of topic stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

Safety Guidelines.

In vitro and in vivo pre clinical study (genotoxicty study, carcinogenicity Testing etc topic)

Efficacy Guidelines.

clinical study in Human subject like Dose responces study, good clinical practices, etc

Multidisciplinary Guidelines.

this is one of the above topic