Process Validation according to FDA

The new guideline "FDA Guidance for Industry Process Validation: General Principles and Practices" of the Food & Drug Administration (FDA) is valid since January 2011. FDA defines Process Validation 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 products. Process validation involves a series of activities taking place over the lifecycle of the product and process.

According to the new guidelines process validation is now a Lifecycle Process with three stages:

Three Stages of Process Validation

  •  Stage 1 Process Design
  • In this phase data from the development and scale up phases are collected and evaluated to build up comprehensive process knowledge. This phase determines critical process parameters (CPP) and critical quality attributes (CQA) and embeds them in the form of a control strategy.

  •  Stage 2 Process Qualification
  • During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing. Among other things, the ultimate specification limits for the process are to be defined. After the process qualification phase is successfully concluded, the product is launched and commercial manufacturing begins.

  •  Stage 3 Continued Process Verification
  • Continued process verification is an enhancement of traditional process validation. This phase includes continuous monitoring of the process beyond the qualification phase. Its objective is to prove that the manufacturing process is always mastered and controlled. To achieve this, a system like PANDA which continuously monitors the process is to be installed. A manufacturer should have gained a high degree of assurance and continuity in the whole manufacturing process before any batch from the process is commercially distributed for consumers use.


Process Validation with PANDA

The data integrating and consolidating analysis system PANDA (Process ANalysis DAtabase) is designed specifically for standard-compliant process validation in pharmaceutical production and supports the continuous manufacturing with its process and quality monitoring.

PANDA is an integrated database system providing information from different source systems like LIMS, MES and ERP. With PANDA raw material, drug substance and batch tree data, as well as development, process and machine data can be structured, linked and aggregated. The system enables you to prove the development of quality attributes and process parameters via data trending over long periods and offers a wide range of analysis, monitoring and data treatment. This allows a high degree of assurance in the performance of the manufacturing process.