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The discipline of cleaning validation is as individual as process validation, but the methods, techniques, and risks are almost identical in all kinds of pharmaceutical manufacture. Process understanding is the magic term when assessing what must be done and the effort to be put into the documentation of equipment status.
A smooth technology transfer and successful cleaning validation in the manufacturing plant can optimise time to market for a new product. Lack of cleaning process understanding can cause expensive surprises in the late phases of bringing products to market. It is, therefore, worthwhile to invest development time in the cleaning process.
