Notebooks characterization

Tests to establish the identity, strength, and purity of the test and control articles need not comply strictly with GLP requirements (e.g., protocol, QAU inspection requirements), but good documentation of anal5dical test results (usually in a laboratory notebook) and retention of raw data for such tests is a good practice. As the development process proceeds and the same material is used in both nonclinical and clinical studies, CGMP principles wiU apply to the production and characterization processes. 

Reagents and reference materials Likely will change but should have some documentation on early characterization Continue to screen for optimal reagents Lot no. and history (notebook reference) Evaluate different reagents and identify critical reagents Determine if sufficient quantities are available and their stability for later bioanalytical needs Include C of A for reference materials in assay validation documents Keep records of source and lot no. Use optimized capture/ detection reagents Use characterized reference standard from final manufacturing process with Cof A Record all lot nos. and sources... 

One of the more recent developments in this area is related to the increasing tendency toward miniaturization. The drive from desktop personal computers to notebook computers to personal digital assistants means that housings must be lighter, yet still provide stiffness, impact resistance and resistance to elevated temperatures. Designers are therefore moving toward thin wall enclosures for computing devices and cellular phones. The PAB s for these applications must therefore have improved melt flow. Recently PC/ABS blends have been introduced to the marketplace for these applications. They are characterized by an increase in melt flow rate (g/10 min) of from 50% to more than 100%. 

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