Method transfer corrective action

Procedure or forms for investigating, reporting, corrective action New or revised methods Allowable circumstances Contract labs Method transfers Audits... 

Use of validated, stability-indicating methods Evaluation of forced degradation products Properly executed method transfer protocols Use of qualified and calibrated equipment by trained analyst Use of qualified and calibrated stability chambers or rooms Handling of OOS and OOT results Timely implementation of corrective actions Stability chambers/rooms... 

Other methods of moisture control employ temperature sensors coupled with models of the conveyor drying process. The temperature drop through the bed of product can be used to calculate the amount of heat transfer occurring as the air passes through the product. If, for example, the product moisture into the dryer suddenly drops, the heat transfer will be reduced. A temperature sensor on the return-air side of the bed will sense this drop in heat transfer as a rise in temperature and the control loop can take corrective action. 

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