ICH and USFDA guidelines are two of the most important sets of regulations for the pharmaceutical industry. Both sets of guidelines aim to ensure the safety, efficacy, and quality of pharmaceutical products. However, there are some key differences between the two sets of guidelines in terms of their scope, jurisdiction, development process, and applicability. ICH…
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has developed a set of quality guidelines that are crucial for the safety, efficacy, and quality of pharmaceutical products. Here’s how these guidelines fit into the different phases of drug development: Preclinical Development Clinical Development Registration Post-approval Overall, these ICH quality…
In this article we discuss on ICH Quality (Q) Guidelines and their relevance to different phases of drug development and manufacturing. ICH Q1A(R2) – Stability Testing of New Drug Substances and Products This guideline provides recommendations on the stability testing of new drug substances and products, including the design of stability studies, testing conditions, and…
All contract service organizations and vendors who supply the cGMP facility with critical supplies, reagents, and equipment must be qualified. This helps to ensure all products have been manufactured in a way that prevents the introduction of adventitious agents or toxic impurities and ensures final product safety, effectiveness, and consistency. However, setting up a supplier/vendor…