Compendial testing

These tests would include compendial tests for Microbial Limits, Sterility, Bacterial Endotoxins, and Antimicrobial Effectiveness. 

It is not required to have prior FDA approval to use an alternative method to a compendial test. According to 21 CFR 314.70 Supplements and Other Changes to an Approved Application, the addition or deletion of an alternative analytical method does not require prior approval and may be filed in the Annual Product Report. However, the equivalency of the alternative method needs to be documented... 

Benzoic Acid USP is specified to contain not less than 99.5% and not more than 100.5% of the substance, calculated on the anhydrous basis. It is to be preserved in well-closed containers. A number of compendial tests have been established by the USP [11]. 

The compendial tests given here are for sorbitol solid. Separate tests for sorbitol solution USP are listed separately in The National Formulary [34]. 

For example, finished-product release specifications such as content uniformity are rarely correlated to clinical evidence rather, they are set according to compendial test standards. Furthermore, the functional relationship between in-process material characteristics and finished-product quality is seldom known at a high level hence, the assigned in-process specifications for some operations may over- or underestimate the true level of process capability. As the level of process understanding in the pharmaceutical industry increases, development of science- and evidence-based in-process and release specifications will improve the reliability of Cpk as a tool for process characterization. 

It has to be said, there are a remarkable mix of topics in this section, ranging through a complete discussion of biotechnology-derived articles (<1045> and <1047>), cell and gene therapy products (<1046>), and validation of compendial (test) methods (<1225>). Specific methods for detection and measurement of suspended particulate matter are discussed in <788>, and there are detailed instructions on how to measure weights, <41>, volume <31>, or temperature <21>. Every student and, indeed, their supervisors need to be aware of what is in this valuable section there is so much valuable information that the compilers cannot be praised enough. 

Validation studies to show that the new preservative does not interfere with application/compendial test. 

Test procedures are written procedures that provide the step-by-step details of how to perform the tests indicated in specifications or SOPs. They indicate the reagents to be used, sources of the chemicals, how the reagents are to be prepared, and the shelf life of the reagents. Also described are the apparatus to be used and special handling and precautions to be followed. At times a compendial test procedure is not in sufficient detail for a laboratory technician to follow exactly. In such a case, the procedure should be written in the necessary detail. A laboratory technician should not run a test without having the proper written procedure. 

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