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OPQ Discusses Ways to Improve Utility of Quality Overall Summary

Posted 23 January 2018 | By Zachary Brennan 

OPQ Discusses Ways to Improve Utility of Quality Overall Summary

The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) on Tuesday released a new white paper discussing ways sponsors can improve the use of a Quality Overall Summary (QOS) submitted in marketing applications.

A QOS is a summary of all quality-related information provided by applicants to regulators in New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs) and Biologics License Applications (BLAs).

The summary is intended to condense integral quality information from a submission to “substantially decrease the effort needed by regulators to understand, summarize, collate, and interpret quality-related data in an application,” OPQ said.

But sponsors are not using the QOS as well as they could, OPQ noted, and there has been a lack of harmonization in terms of regulatory expectations for the QOS across different regions of the world, contributing to its underutilization as an effective assessment tool.


“While the QOS holds great promise as a means of promoting effective communication between applicants and regulators, it has the potential to more effectively impact the efficiency and/or quality of regulators’ assessments. One approach to make the QOS more effective is the use of a question-based review (QbR) QOS for the assessment of ANDAs,” OPQ said.

However, some applicants outside the generic drug industry are reworking the current QOS framework in regulatory submissions and this latest white paper describes key considerations when creating a QOS that: explains product and process development in a patient-focused context, effectively summarizes an overall control strategy and guides the regulator through a submission.

“While these are potential challenges for applicants and regulators, the ultimate beneficiary of any development regarding the QOS should be the patient. Improvements in application assessment resulting from the QOS, including better communication and increased assessment efficiency and quality, should lead to improved access to safe, effective, quality drug products,” OPQ said.

A Regulatory Perspective on the Quality Overall Summary: Putting the Pieces Together

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