In the context of the International Council for Harmonisation (ICH) guidelines, specifically ICH Q7, API stands for Active Pharmaceutical Ingredient.
Definition of API according to ICH Q7
ICH Q7 defines an Active Pharmaceutical Ingredient (API) as:
"Any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient in the drug product."
This means the API is the component of a drug product that provides the intended pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
Key Aspects of the API Definition:
- Intended Use: The substance or mixture is specifically intended to be used in the manufacturing of a drug product.
- Active Ingredient: When incorporated into the drug product, it becomes the component responsible for the therapeutic effect.
- Broad Scope: Covers substances used for various purposes, including diagnosis, treatment, and prevention of diseases.
Implications of the API Definition in ICH Q7
The ICH Q7 guideline, "Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients," focuses on the manufacturing of APIs. Therefore, understanding the definition of API is crucial for the following:
- GMP Compliance: Manufacturers of APIs must adhere to GMP principles to ensure the quality, safety, and efficacy of the final drug product.
- Quality Control: Proper testing and quality control measures are essential to verify the identity, purity, and potency of the API.
- Regulatory Compliance: Regulatory agencies worldwide rely on ICH guidelines to evaluate the manufacturing processes of APIs.
Examples of APIs
Examples of APIs include:
- Paracetamol (acetaminophen), used as an analgesic and antipyretic
- Atorvastatin, used to lower cholesterol levels
- Amoxicillin, an antibiotic
Summary
In summary, within the framework of ICH guidelines, particularly ICH Q7, API refers to the Active Pharmaceutical Ingredient, which is the component of a drug product that provides the intended therapeutic effect. Its manufacturing is subject to stringent GMP requirements.
