Continued Process Verification - Stage of Continuous process validation

-Continued Process Verification mean assuring that during routine production the process remains in a state of control. 

- Continued Process Verification is the stage of Stage of Continuous process    validation.

-The goal of the Continued process verification third validation stage is continual assurance that the process remains in a state of control (the validated state) during commercial manufacture. 

- Adherence to the C-GMP requirements, specifically, the collection and evaluation of information and data about the performance of the process, will allow detection of undesired process variability. Evaluating the performance of the process identifies problems and determines whether action must be taken to correct, anticipate, and prevent problems so that the process remains in control.

-An in-process  procedure to collect and analyze product and process data that relate to product quality must be established.

-The data collected should include relevant process trends and quality of incoming materials or components, in-process material, and finished products.

-The data should be statistically trended and reviewed by trained personnel. The information collected should verify that the quality attributes are being appropriately controlled throughout the process. 

-Procedures should describe how trending and calculations are to be performed and should guard against overreaction to individual events as well as against failure to detect unintended process variability.

-Production data should be collected to evaluate process stability and capability. The quality unit should review this information. If properly carried out, these efforts can identify variability in the process and/or signal potential process improvements. 

-Good process design and development should anticipate significant sources of variability and establish appropriate detection, control, and/or mitigation strategies, as well as appropriate alert and action limits. However, a process is likely to encounter sources of variation that were not previously detected or to which the process was not previously exposed. 

-Many tools and techniques, some statistical and others more qualitative, can be used to detect variation, characterize it, and determine the root cause. We recommend that the manufacturer use quantitative, statistical methods whenever appropriate and feasible. 

-Scrutiny of intra-batch as well as inter-batch variation is part of a comprehensive continued process verification program under. 

-We recommend continued monitoring and sampling of process parameters and quality attributes at the level established during the process qualification stage until sufficient data are available to generate significant variability estimates.

-These estimates can provide the basis for establishing levels and frequency of routine sampling and monitoring for the particular product and process. Monitoring can then be adjusted to a statistically appropriate and representative level. Process variability should be periodically assessed and monitoring adjusted accordingly. 

-  If any change in process it should be documented through the change control procedure. - Refer Change control management in Pharma