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The most important approach to maximize the chance that the NDA or BLA is received favorably is to strive for clarity, to avoid exaggerations, and to discuss rather than hide negative findings and deficiencies. Avoid claims that cannot be substantiated, and keep in mind the advice that if something is not documented it is rumor.
When submitting the marketing application for your drug product, the CMC section must show that your product can be manufactured consistently and to quality standards. Having a pharmaceutical development report of the project provides a single go to reference for explanation of processing methods, information on tests and analytical methods, a scientific approach to process scale-up, and should provide the necessary documentation to satisfy CMC requirements.
An important facet of the development report is that it describes how quality assessment and risk management principles were applied during the development and how the review process accommodated variability.
A living document
The “FDA Guidance for Industry Q8 (R2) Pharmaceutical Development,” discusses the suggested contents for a regulatory submission and explains the intended purpose of a development report. It should provide understanding of the product and its manufacturing process to reviewers and inspectors, and it can be updated with new information learned during the lifecycle of the product, thus making it a “living” document.
Simplistically, a living document is one that is created with the expectation that it will be updated. Rather than seek to complete the “final” version, the document is created and assigned version numbers, which change when the document has been updated, reviewed, and approved with noteworthy changes.
Why Your Development Report Should be a Living Document
It is unfortunately acceptable in many circles that a report on activity can be created after the activity has concluded. For your development report there are several reasons this tact should not be taken, and the report should be treated as a living document almost from the beginning of the project.
Proper Documentation and a Project Outline/Checklist
In developing your drug product, you should study and understand the relevant FDA regulations for submitting an NDA even before the research phase of your product. Your understanding of the requirements enables you to ensure the project contains all the needed elements for success.
Documentation is often overlooked at the outset of a project because of the misconception that you don’t need to bring in writers until you’re ready to create your NDA submission documents. This thinking is a mistake. Companies that use a disciplined, systematic approach from the beginning, and use the project documentation to drive that approach, move more efficiently and cost effectively through the process than companies who don’t.
By defining the outline and contents of your pharmaceutical development report at the beginning, you can create a guide to use throughout the project. The outline can be used as an audit checklist to ensure all steps are being taken and are properly documented.
FDA guidance makes several references to using a scientific approach and emphasiz regulatory flexibility if they can certify that you have used a scientific methodology. The science used to develop the drug product should be rigorous and should be rigorously recorded.
In regulatory examinations, products missing well-documented explanations for decisions and a historical chain of events can raise red flags with the reviewers. Not having and executing a thorough documentation plan can cause issues and delay in getting approval.
Consistent and Suicient Documentation
By treating your development report as a living document, you can ensure you have consistent and sufficient documentation. To minimize questions from the regulator, make sure your document has the appropriate content items, including data on the manufacturing process, sample testing, and container stability, and ensure that terms and references are consistent throughout the documentation.
Time and Cost Savings
Besides providing a quality report that will help the overall approval process, creating a living development report will ultimately mean time and cost savings during the NDA authoring. Creating the documentation from the start enables better and more efficient client reviews, and less research needed by the writers.
To help ensure an efficient process, experienced technical writers and industry consultants should coordinate the writing and document preparation. By bringing in knowledgeable help who understand documentation, you can minimize the overall effort because it will be prepared according to FDA expectations.
The pharmaceutical development report provides inspectors a comprehensive explanation of both your product and the proposed manufacturing process. By creating a living document that demonstrates the proper level of scientific process and knowledge, you will ensure a degree of regulatory flexibility and create a history for the life of your product.
Although every section of the CTD Module 3 plays a vital role in supporting the ultimate approval of a new drug, several sections now stand apart from each other in a few respects. Traditionally, the manufacturing process description (S.2.2 and P.3.2), specifications (S.4.1 and P.5.1), analytical procedures (S.4.2 and P.5.2) and stability (S.7 and P.8) sections served as an introduction to and summary of all the compliance data available on the drug and continues to be closely reviewed.
Now more than in the past, conformance sections Pharmaceutical Development, afford the opportunity to craft discussions, arguments, explanations and justifications, so that supportive data can be highlighted, and less-than-stellar findings put in perspective. These sections can therefore influence the perspective of the reviewers more so than in the past, so it is preferable to tackle difficult potential issues head-on rather than wait for regulatory reviewers to notice problematic data.