Documentation analytical

Arctium lappa L. (burdock) is used as food, preventive and medical remedy. East medicine usually uses it as a fresh root of its first year of vegetation. In some countries burdock is cultivated for use as food and a medicinal herb. Thus the development of analytical documentation for this plant raw material is essential. 

Proper production process execution and performance of analytical procedures relies on comprehensive, clearly stated, and unambiguous documentation. This is necessary whether the document is used to initiate an activity (e.g., process, method, work instruction) or contains results that will be reviewed by someone else. A master batch record that can be easily misinterpreted by trained operators is a serious source of process variability. Similarly, if the analytical method is not written in a clear, concise, and sufficiently detailed manner, interpretation may be different from analyst to analyst, also resulting in higher than expected variability and perhaps an OOS result. Process and analytical documentation should be written with the user in mind and authored by individuals with intimate familiarity with the task to be carried out. The written procedures should be concise or crisp, yet contain sufficient technical detail to lead trained operators and analysts through the same set of operations with the outcome being the same when applied to the same material(s). 

AUSM - Analytical Documentation," Volumes I, II, and III. Assembled by U.S. Environmental Protection Agency, Industrial and Environmental Research Laboratory, prepared by Universities Research Group on Energy. March 1983. 

Analytical documentation requirements during the life cycle of a pharmaceutical product—from initial candidate screening and selection, through entry into humans/IND, to NDA and postapproval marketed product support—are discussed in this book. Most of the information is based on US FDA and ICFF guidelines EU requirements are not substantially different. 

This chapter describes analytical documentation needs during the life cycle of a pharmaceutical product—from initial candidate screening and selection,... 

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. 

As shown in Figure 2, analytical documentation comprises a variety of analytical reports. The major types of analytical documentation are frequently... 

Analytical documentation during the discovery phase consists of the following items ... 

TABLE I Analytical Documentation Key Product-Specific Documents during Development... 

Analytical documentation during phase 0 to enabling EIH generally consists of the follotving items ... 

Analytical documentation during phase 2 includes IND amendments and internal development reports ... 

Analytical documentation for an sNDA or a new NDA is the same as that for the drug product of the first NDA. Additionally, comparative data may be needed to illustrate the similarities or differences versus the reference marketed product. 

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 ... 

There are three major types of analytical documentation prepared to support investigational and marketed pharmaceutical products ... 

Honeywell Gas book, Honeywell gas detection, Honeywell http //www.honeywellanalytics. com/ /media/honeywell analytics/documents/english/11296 gaS book v5 0413 lr en.pdf la=en. 

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