What are the Critical Parameters affecting Process Validation?

Critical Parameters affecting Process Validation

The critical parameters should normally be identified during the development stage or from historical data or during manufacturing and process control. Process Validation involves three stages and now will identify the critical parameters in these stages:

Stage-1: Process design

Process design is the activity of defining the commercial manufacturing process. The goal of this stage is to design a process suitable for routine commercial manufacturing that can consistently deliver a product that meets its critical quality attributes. A product development activity provides key inputs to the design stage, such as the intended dosage form, the quality attributes, and a general manufacturing pathway. The functionality and limitations of commercial manufacturing equipment should be considered, also contributions of variability by different component lots, production operators, environmental conditions and measurement system in the production setting.

Stage-2: Process Qualification

During this stage, the process design is confimed as being capable of reproducible commercial manufacturing. It confirms that all established limits of the critical parameters are valid and that satisfactory products can be produced even under worst-case condition. This stage has following elements – Qualification of Utilities and Equipment.

Stage-3: Continued Process Verification

Continually assure that the process remains in a state of control during commercial manufacturing. A system or systems for detecting unplanned departures from the process as designed is essential. The following points to be considered in Continued Process Verification:

⇨ Collection and evaluation of information and data about the performance of the process will allow detection of process drift. 

⇨ Evaluation should determine whether action must be taken to prevent the process from drifting out of control.