Continuous process validation

Continuous process validation:

Continuous process validation is an alternative approach to traditional process validation in which manufacturing process performance is continuously monitored and evaluated (ICH Q8).

Continuous process validation can be used in addition to , or instead of, traditional process validation.

Continuous process validation:

defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process. This guidance describes process validation activities in three stages.

Following are the tree stage of Continuous process validation

1. Process Design

2. Process Qualification

3. Continued Process Verification