FDA Explains its Wish List for Quality Overall Summary in NDAs and BLAs
[Posted on: Thursday, January 25, 2018] FDA published a white paper this week to explain what its reviewers wish to see in the Quality Overall Summary (QOS) giving some useful and practical tips to improve the marketing approval applications. Module 2 of an NDA, ANDA and BLA application contains the QOS which summarizes the manufacturing and characterization (CMC) information about the product for the regulators. It is intended to condense and summarize integral manufacturing information from Module 3 to make it easy for the FDA reviewers to understand, summarize, collate, and interpret quality-related data in the application. However, frequently the QOS is poorly written having the opposite effect during the review. FDA explains that while creating the QOS that the applicant should first explains product and process development in the context of clinical relevance to the patient by linking quality to clinical performance. The QOS should summarize how the process and the resulting product meets the patient’s needs and achieves the intended performance. Quality information should be presented in the context of risk to patients; high quality reduces risk. Second, the QOS should summarize the overall control strategy explaining how the submission supports the manufacturer’s ability to provide a product that consistently and safely meets labeling claims and how the submission supports commercial manufacturing of the product. Third, the QOS should guide the regulator through the submission by identifying any innovative elements of manufacture that may present new previously unknown issues for the quality assessment, explaining any pre-application meeting agreements and commitments, providing data summaries that explain key data and findings with adequate cross references and links to these sections in Module 3. Additionally, the QOS should help the regulator easily locate and access key data in Module 3. QOS should also summarize the information presented in the application and that planned via post-approval commitments and any planned lifecycle management activities. The QOS should be consistent with Module 3. Ideally, the regulator should be able to use the QOS to initiate the assessment of potential risk to the patient, and the control of such risk, in the commercially manufactured product. QOS is an important component of an application, not just for market approval but also of an IND. The white paper goes a long way to explain FDA expects and sets the goal for the writers of an NDA, BLA, ANDA and IND applications.
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