FDA Guidance 2011 and EMA Guideline 2014

Both authorities have recently published guidelines for Process Validation which will be of considerable importance for pharmaceutical industry.

FDA Guidance for Industry Process Validation: General Principles and Practices

The current FDA Guidance (January 2011) describes general principles and practices for Process Validation. The guidance includes concepts and principles that can be used by all manufacturers to validate their processes.

Details for the Process Validation according to FDA

EMA Guideline on process validation for finished products

The current EMA guideline (February 17th 2014) is brought in line with CGMP-protocols (Current Good Manufacturing Practice) and ICH documents (International Conference on Harmonization).

It shows a fairly comparable approach to process validation as the analogous protocols published by the US-FDA. General considerations and goals are quiet similar.

Process Validation according to EMA.



The Perspective of Process Validation

Depending on the target market of the drug in the future (within 3 5 years) either the implementation of Continued Process Verification (CPV) is expected or the pharmaceutical manufacturer can choose between Continuous Process Verification and Traditional Process Verification (TPV). For larger and globally established pharmaceutical companies this raises the question of whether to favor the Continued Process Verification (CPV), which is middle and long term the more efficient method to support the continuous improvement process.

Once data integration and the tools involved are mastered this method promotes significant the organizational processes, effectiveness and cost reduction. Thus, e.g. the amount of the elaborate quality and release controls can be reduced. Via Continued Process Verification (CPV) it is possible to reduce the process risk by the continuous monitoring with statistical analyses such as control charts.