Cleaning validation: Verifying the performance of the cleaning process.
[Fact Sheet] Effectiveness of TOC in Each Phase of Cleaning Validation (Design, Validation, Verification)
- Purpose and Challenges of Cleaning The cleaning process is designed to effectively remove compounds, ensuring that no decomposition products or residual cleaning agents are left in the manufacturing equipment, allowing it to be used for the production of the next batch. Relying on specific analytical methods can take years from design/development/completion and requires significant manpower.
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- Solutions Compared to specific analytical methods such as HPLC, TOC offers a simpler development process and can also verify the removal of excipients/degradation products/cleaning agents. Considerations when implementing TOC include confirming key cleaning process parameters (TACT) to improve/change the new cleaning process. - Challenges Specific analytical methods can prove that individual compounds were not carried over to the next batch, but they cannot demonstrate the completion of the cleaning process. TOC-based analytical methods are effective for verifying the performance of validated cleaning processes and cleaning parameters. Many pharmaceutical companies are adopting TOC-based methods rather than specific analytical methods that measure particular substances. - Industry Guidance In 2010 and 2012, PDA published Technical Report No. 49, which addressed considerations in biotechnology. This report was created by a team of experts dispatched by the FDA and promotes new focal points and shifts in thinking regarding cleaning validation. For more details, please refer to the fact sheet.
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300_00247
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Cleaning validation
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