Standardization of Report Formats for Chemistry/Pharmacy Documents

Abstract

Review of the chemistry/pharmacy sections of submissions by regulatory agencies has frequently resulted in deficiency letters from these agencies. Addressing regulatory agency letters typically requires an extensive use of time and resources. The worst case scenario is if preparation time for a response letter translates into a delay in product approval. Lack of accessibility of information within documents in a submission has been identified as a root cause of regulatory agency questions. As a potential solution to the problem, standard report guidelines are being developed within American Cyanamid Co. for all key chemistry/pharmacy submission report types. Each report guideline contains the report data requirements, the standard report format, an electronic template, and detailed instructions on report preparation. Four standard report guidelines have been completed and are implemented at this time. A scientific writing course was tailored to each guideline, with the assistance of a specialty writing consulting firm. As an introduction to the guideline, the writing course is offered to report authors shortly after issuance of the corresponding guideline. Work will continue to standardize and prepare guidelines for all chemistry/pharmacy report types included in regulatory submissions.