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Stability test Good Manufacturing Practice

Current Good Manufacturing Practices [135] establish the requirements for maintaining a stability program and require that most pharmaceutical dosage forms have an established expiration date supported by test data [134]. There are few allowable exceptions. [Pg.169]

Code of Federal Regulations, Title 21, Food and Drugs, Part 211, Current good manufacturing practice for finished pharmaceuticals, Subpart I, 211.166 Stability Testing. [Pg.173]

Establishment of good quality control techniques and good manufacturing practices and of facilities for formulation and packaging development activity to undertake compatibility and stability tests as well as safety testing and bioavailability studies. [Pg.183]

Good Manufacturing Practices for Stability Testing of Pharmaceutical Products Containing Well Established Drug Substances in Conventional... [Pg.3]

Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Page 24 The test procedures used in stability testing should be vahdated and be stability-indicating... [Pg.143]

It is good practice to check from time to time that the stability of the instrument is within the manufacturer s specification. It is necessary to test the reliability of the stopped-flow instrument using control experiments that test a range of parameters such as the dead time, mixing efficiency and signal output. In general, these tests will be the same for the instrument in the configuration for fluorescence studies as that for absorbance studies. [Pg.6314]

See other pages where Stability test Good Manufacturing Practice is mentioned: [Pg.383]    [Pg.408]    [Pg.203]    [Pg.249]    [Pg.139]    [Pg.183]    [Pg.557]    [Pg.697]    [Pg.314]    [Pg.55]    [Pg.57]    [Pg.2303]    [Pg.1685]    [Pg.1785]    [Pg.442]    [Pg.100]    [Pg.282]    [Pg.350]    [Pg.302]    [Pg.184]    [Pg.175]    [Pg.110]    [Pg.17]    [Pg.138]    [Pg.254]    [Pg.362]    [Pg.3635]    [Pg.421]    [Pg.847]    [Pg.220]    [Pg.108]    [Pg.230]    [Pg.168]    [Pg.182]    [Pg.80]   
See also in sourсe #XX -- [ Pg.309 ]



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