Drug products testing

A statement of the results of tests and how the results compare with established standards of identity, strength, quality, and purity for the component, drug product container, closure, in-process material, or drug product tested. 

T. Mirza, Q. Liu, R. Vivilecchia, Y. Joshi, Comprehensive validation scheme for in situ fiber optics dissolntion method for pharmaceutical drug product testing, J. Pharm. Sci., 98(3), 1086-1094 (2009). 

The results imply that for the majority of drug products tested, there does not appear to be a serious problem with regard to the presence of N-nitroso compound contaminants. 

Product testing is one of the most important functions in pharmaceutical production and control. A significant portion of the CGMP regulations (21 CFR 211) pertains to the quality control and drug product testing. 

An adequate number of batches of each drug product shall be tested to determine an appropriate expiration date and a record of such data shall be maintained. Accelerated studies, combined with basic stability information on the components, drug products, and container-closure system, may be used to support tentative expiration dates, provided full shelf-life studies are not available and are being conducted. Where data from accelerated studies are used to project a tentative expiration date that is beyond a date supported by actual shelf-life studies, there must be stability studies conducted, including drug product testing at appropriate intervals, until the tentative expiration date is verified or the appropriate expiration date determined. 

Frequency of testing should be sufficient to establish the stability characteristics of the drug product. Testing will normally be every three months over the first year, every six months over the second year and then annually. 

Frequency of testing should be sufficient to establish the stability characteristics of the drug product. Testing will normally be every 3 months over the first year, every 6 months over the second year, and then annually. Matrix-ing or bracketing can be used if justified. [ICH Q1A] A minimum of four test stations (e.g., at 0,2,4, and 6 months)... 

Where data from approval and validated accelerated studies are used to project a tentative expiration date that is beyond a date supported by actual shelf life studies, must be stability studies conducted, including drug product testing at appropriate intervals, until the tentative expiration date is verified of the appropriate expiration date determined. 

Smela M J (2005) Regulatory considerations for stability indicating analytical methods in drug substance and drug product testing. Am Pharm Rev 8 51-54. 

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