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Rob Stijlen
Home | Change and Risk Management in Continuous Process Validation
February 19, 2016

Change and Risk Management in Continuous Process Validation

… is a topic with plenty of potential with respect to Annex 15 that was recently enacted.

The pharmaceutical industry has been speaking about this hot topic for months. But what makes the enactment of the new European guideline, Annex 15, so special?

The new guideline is a paradigm shift where the “Guideline for Industry, Validation: General Principles and Practices,” which has been valid since January 2011, puts forth the same contents — its 3‑stage model, which begins very early in the development of a production process:

  • Stage 1 — Process design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.
  • Stage 2 — Process qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.
  • Stage 3 — Continued process verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

However, the guideline for industry continued to allow data generation through an established process validation using three conformance lots, which were sampled, tested and statistically evaluated. This was also accepted without objection by the authorities for submissions and audits, since the conversion from the traditional process validation to CPV (Continuous Process Validation) is tedious.

CPV Product Life Cycle

Graph: Product Life Cycle

To be able to implement the three-stage approach to CPV, the conditions must first be created in the development organization of the company.

Quality by Design is the tool to be able to approach the process design, to further develop the process in a controlled and documented manner and to define the CQAs (Critical Quality Attributes) as well as the CPP (Critical Process Parameters) using PFMEA (Process Failure Mode and Effects Analysis) based on the process knowledge already acquired. The PPQ (Process Performance Qualification), comparable to the traditional process validation, is implemented at the end of the second stage and is meant to substantiate the process suitability and process reproducibility.

Continuous Process Validation, the third stage, means the continuous monitoring of the process and (statistical) evaluation of the generated data, including the data received from stability studies and studies that result from non-conformities and complaints.

 

The biggest advantage of the three-stage approach is the already statistically evaluable data volume for the implementation of the PPQ.

This results in a considerably clearer and more accurate image of the processes, which in turn meets the requirement of the authorities.

In our expert presentation at the symposium “Continuous Process Validation” of ChemAcademy on 29 February 2016, we will deal with this third stage in detail. In addition, we will shed light on the advantages of the improved approach compared to the traditional approach and also discuss the importance of change control management and risk management according to ICH Q9.

Please finde here more information about the symposium of ChemAcademy and our expert presentation on “Change and Risk Management in Continuous Process Validation”.