Home » Remote Guides Express » Who Quality Overall Summary?

Who Quality Overall Summary?

James H. Sterling • • 6 min read
Who Quality Overall Summary?

The Quality Overall Summary (QOS) is a summary of all quality-related information provided by applicants to regulators in drug marketing or licensing applications, including New Drug Applications (NDAs), Abbreviated New Drug Applications

Abbreviated New Drug Applications
An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.
› abbreviated-new-drug-application-anda
(ANDAs), and Biologics License Applications (BLAs) in the United States.

Which module of CTD contain QOS?

The QOS is located in Module 2.3 of the CTD format, and is required for submission of marketing applications.

What is pharma specification?

Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval. Specifications are one part of a total control strategy for the drug substance and drug product designed to ensure product quality and consistency.

James H. Sterling
Author

James H. Sterling

James Sterling reports on renewable energy developments, climate policy, ecological conservation, and green tech innovations around the globe.