Drug products continuous monitoring

As the maturity of the process increased, only the key parameters would require continued monitoring. Ultimately, the data collected on these properties would permit the generation of material specifications. If the work had been performed properly, then it would be possible to specify limits for the-appropriate bulk drugs and raw materials that would ensure that the final product always was satisfactory. These guidelines would naturally apply only to the specific formulation, but their implementation would enable manufacturers to deliver their products with a greater degree of security than is now possible. 

A. Continuous Monitoring of Impurity Profile in Drug Product... 

After approval is received for the drug product, stability studies are continued to support commercialization of the drug product. Representative lots are put on stability station for annual product monitoring. 

ICH QIO illustrates a model for a pharmaceutical quality system that can be implemented throughout the lifecycle of a product. This primary objective is achieved through the implementation of three specific goals, including (1) establish, implement, and maintain a system that ensures the delivery of high-quality drug product with the appropriate quality attributes to consumers (2) develop an effective monitoring and control system that continually assesses process performance and product quality and (3) continually identify and implement... 

The production of some products can be controlled simply by inspection after the product has been produced. In other cases, as with the continuous production of food and drugs, you may need to monitor certain process parameters to be sure of producing conforming product. By observing the variability of certain parameters using control charts, you can determine whether the process is under control within the specified limits. 

The second difference relates to the definition of a cutoff time point for the evaluation of the difference factor and the Rescigno index. When cumulative data are available, evaluation of the difference factor or the Rescigno index usually requires a reference data set in order to define the cutoff time point for index evaluation (30). For the evaluation of fl and the , i.e., when the difference factor and the Rescigno index are evaluated from non-cumulative data, this difficulty does not exist, provided that the release process has been monitored up to the end (i.e., until dissolution of the drug is complete). At this point, it is worth mentioning that a similar conclusion cannot be drawn for the similarity factor (31) because application of this index to non-cumulative data is set apart by the careful scaling procedure required, in addition to the existence of a reference data set. The reason is that this index can continue to change even after dissolution of both products is complete. 

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