Regulatory analytical documentation

This chapter is not intended as a cookbook. It does not provide step-by-step directions on how to prepare analytical documentation for a perfect IND, NDA, or GMP inspection. However, the information presented on the following pages will aid in identifying the critical documents (and their contents) necessary to attain these objectives. A list of related regulatory guidance and policy documents (FDA and ICH) is provided in Appendix I to assist the reader in locating more detailed information on specific topics. 

Although some documents are required only for NDA submission, the major types of analytical reports for regulatory submission are very similar for IND and NDA submissions. The differences in these reports for IND or NDA submission primarily concern the amount of data (e.g., number of batches, duration of stability studies) and level of detail. Also, the requirements for amendment of the information are different. The major types of analytical documents common to IND and NDA submissions are the following ... 

Rozet, E., Ceccato, A., Hubert, C., Ziemons, E., Oprean, R., Rudaz, S., Boulanger, B., Hubert, P. Analysis of recent pharmaceutical regulatory documents on analytical method validation. J. Chromatogr. A., 1158, 2007, 111-125. 

Regulatory authorities recognize that, in spite of all the control systems put in place, deviations and changes are sometimes inevitable. A robust GMP system includes procedures to handle, review, and approve changes in raw materials, specifications, analytical methods, facilities, equipment, processes, computer software, and labeling and packaging. All the changes have to be documented with references for traceability. 

There are many reasons for the need to validate analytical procedures. Among them are regulatory requirements, good science, and quality control requirements. The Code of Federal Regulations (CFR) 311.165c explicitly states that the accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Of course, as scientists, we would want to apply good science to demonstrate that the analytical method used had demonstrated accuracy, sensitivity, specificity, and reproducibility. Finally management of the quality control unit would definitely want to ensure that the analytical methods that the department uses to release its products are properly validated for its intended use so the product will be safe for human use. 

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