Process Development and Validation

Based on their industry experience with Process Excellence pioneers such as Johnson & Johnson, Fleet pride themselves on the development and optimisation of processes for robustness.

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Where a process is intended for routine manufacture, Fleet will always advise on appropriate approaches to assure reproducibility – and to meet regulatory expectations with respect to process robustness and validation.

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These may include techniques such as Failure Mode and Effect Analysis (FMEA) to identify key process and raw material variables, and Design of Experimentation (DoE) principles such as reduced factorial arrays to confirm that these variables are adequately controlled in the final process.

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Attention to such factors is particularly critical if processes are scaled up from R&D to production, and Fleet possess the necessary in-depth expertise to avoid scaling pitfalls.

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Where formal process validation is required, Fleet are happy to assist with the preparation of the necessary protocols and reports.