Analytical development report

Assignment of a definite or probable cause should be simplified by the availability of analytical development reports prepared during various phases of drug substance or product development. If analytical development during drug development was carefully conducted and validated and was well documented, sufficient information should be available to expedite and facilitate the investigation. 

It is extremely beneficial to have a comprehensive analytical development report that provides the scope of each analytical method, chronology, rationale for changes, and equivalency or superiority of the optimized methods. Usually, the analytical development report for each method, along with the validation report, facilitates the technology transfer process. 

The analytical development report is a documented summary and logic flow of all essential analytical information acquired during the R D phase of the project. In many cases, this report serves a variety of purposes it is a repository of all important analytical information pertaining to the project and is therefore a source document for the quality unit, and it is also used in the preparation of the site inspection at the time of product approval. All information contained in this report must be traceable to raw data and other reports, if applicable. Table 3 contains a summary of all information that should be contained in the analytical development report. The format of the report is not critical, but the information must be present. For further details on the various sections and chapters in this report, the reader is referred to other chapters in this text that describe the details therein. 

TABLE 3 Suggested Content of the Analytical Development Report... 

The analytical development report is one of the most valuable documents written by the R D unit during the development process. If properly composed and completed, it can serve as a powerful document for many years after product approval. 

Analytical development reports—drug substance and drug product... 

It is extremely beneficial to have comprehensive analytical development reports describing the evolution of the analytical methods for a new drug substance or... 

The contents of the analytical development report should specifically address the following items ... 

It is extremely beneficial to have comprehensive analytical development reports describing the evolution of the analytical methods for a new drug substance or drug product. Separate reports are prepared for the drug substance and product. The reports trace the chronological history of the IND specifications up to the proposed NDA specifications, itemizing changes in tests, specifications and methods associated with major revisions. Additionally, the development of key methods used to assure identity, potency, purity/impurities, and performance (e.g., particle size or dissolution) should be discussed in detail. Summaries for the... 

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