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For your purposes of this chapter, the phrase “process validation” will probably be retained as its conventional activity wherever the verification of your production process is completed. In the event the cycle features a sanitization/disinfection phase, thermal strips or Organic indicators can be utilized through the design period to establi
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Section 211.one hundred thirty-Packaging and label functions, avoidance of mixup and cross contamination, identification and handling of submitted drug merchandise containers which can be put aside and held in unlabeled issue, and identification of the drug product by using a lot or Handle range that allows willpower of the heritage with the manufa