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Q7A GMP Guidance for Active Pharmaceutical Ingredients

he scope of this guidance relates to the API manufacturing for usage in human medical products

It applies to the production of germ-free APIs only up to a point closely before the APIs are made sterile. This recommendation does not cover decontamination and sterilized processing of active pharmaceutical ingredients (APIs) but should be implemented in agreement with GMP guidance for medical products as mentioned by domestic authorities.

This document covers the API manufacturing that are made by chemical synthesis, fermentation process, isolation/recovery from natural sources, other biotechnology methods, or any recipe of the above processes.


However, this guidance includes API manufacturing using plasma or blood as main materials;

it excludes whole cells, whole plasma and blood, blood and plasma byproducts, all vaccines and gene therapy APIs. Others that may be subjected to GMP but are not covered by this guidance are cell substrates and first processes. The guidance does not apply to medical gasses, and bulk packed medicinal products (e.g., tablets or capsules in bulk containers), or radiology pharmaceuticals.

An API primary or beginning ingredient is a raw material, a transitional product, or an active pharmaceutical ingredient that is used in the manufacture of API and is integrated as an important fundamental portion in the making of the API. An API primary or beginning ingredient can be produced in-house, a material purchased from other suppliers under contract, an article of commerce, or commercial agreement. API primary or beginning ingredient usually have distinct chemical properties and structure.

For synthetic processes, the company should designate and document the justification for the point at which API manufacturing begins, this is known as the point at which API primary or beginning ingredients are arrived at through the process. For extra processes, this justification should be used on an individual basis.

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