Question

"ICHQ7A are guidances observed for the manufacture of ________________, while FDA's cGMPs in CFR21 part 211 are regulations that mainly cover the manufacture of _______________."

-Raw materials:In-process materials
-Biologics: Pharmaceutical drugs
-API:Finished drug pharmaceuticals
-Generic drugs: Biologics
-Finished drug products: Active Pharmaceutical Ingredients

Answer 1

ICHQ7A guidance relates to the manufacturing of Active Pharmaceutical Ingredients, while FDA's cGMPs for pharmaceuticals focus on the manufacturing of finished drug products, ensuring they adhere to quality standards.

Step-by-step explanation:

ICHQ7A are guidances observed for the manufacture of Active Pharmaceutical Ingredients (APIs), while FDA's cGMPs in CFR21 part 211 are regulations that primarily cover the manufacture of finished drug pharmaceuticals.

The current Good Manufacturing Practices (cGMPs) enforced by the FDA ensure that drugs meet the quality standards appropriate for their intended use before they are sold.

In contrast, ICHQ7A provides an international standard for API manufacturing which helps to ensure safety, quality, and efficacy of the APIs used in pharmaceuticals.