1. Active Pharmaceutical Ingredient (API) and Excipient:
A drug comprises of two portions: API and Excipient. An excipient is the inert portion of the drug whereas API is the chemically active portion. Chemically active portion refers to the part of the drug which created the desired effect in the body.
2. Change Control:
The systematic approach to managing all changes made to a product or systems. The purpose is that all changes identified, reviewed, approved, archived and very well evaluated.
3. Raw material:
A raw material refers to a starting material, reagents, processing aids or solvents that are used to manufacture an API or an intermediate.
4. Impurity:
Any undesired entity present in any component of an API or Intermediate.
5. Intermediate:
An intermediate is a material that is produced during the manufacturing of API that undergoes further molecular change or processing to become an API. This is to be noted that as the intermediate is produced during the manufacturing of an API, the manufacturer shall decide the point where the initiation of API takes place.
5. Manufacturing:
Manufacturing in ICH refers to all the operation including receipt of material, production, packaging, repackaging, labeling, relabeling, storage, dispatch. It also quality control, release and all the other related control.
6. Sampling:
Sampling is a technique in which a predefined quantity is taken from the whole lot for the purpose of analysis.The result of the analysis decides the fate of the whole lot.
2. Change Control:
The systematic approach to managing all changes made to a product or systems. The purpose is that all changes identified, reviewed, approved, archived and very well evaluated.
3. Raw material:
A raw material refers to a starting material, reagents, processing aids or solvents that are used to manufacture an API or an intermediate.
4. Impurity:
Any undesired entity present in any component of an API or Intermediate.
5. Intermediate:
An intermediate is a material that is produced during the manufacturing of API that undergoes further molecular change or processing to become an API. This is to be noted that as the intermediate is produced during the manufacturing of an API, the manufacturer shall decide the point where the initiation of API takes place.
5. Manufacturing:
Manufacturing in ICH refers to all the operation including receipt of material, production, packaging, repackaging, labeling, relabeling, storage, dispatch. It also quality control, release and all the other related control.
6. Sampling:
Sampling is a technique in which a predefined quantity is taken from the whole lot for the purpose of analysis.The result of the analysis decides the fate of the whole lot.
