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Wednesday, June 8, 2011

Documentation of Cleaning Process and Its Validation

Inspection of Cleaning process and its validation its documentation:
FDA inspection many times put great emphasis on the documentation of cleaning procedures and cleaning validation process they examine in detail the specificity of the cleaning procedure and its validation, and the relevancy and quality of required documentation.
Important amongst are SOP’s batch records, and log sheets , logs sheets of system which may require special cleaning after each step. There should be proper documentation of systems which are complex in operation and require operator training. Each critical step in cleaning process must be documented for such systems, and completed details about the cleaning operation is required to be maintained in case of equipments with complex systems, starting from identification of person cleaning, and the final authorization for the competition of cleaning process. Where as for simple processes just a documentation of completion of cleaning process will be enough.   good manufacturing practices
Further some other factors like as history of cleaning, variability of test results, contaminant levels after cleaning, should be considered to generate the required documentation of cleaning process, Documentation must establish the complete evidence that the cleaning process carried out is acceptable and is effective , it should determine the operators performance in the cleaning process as well. Quality assurance system must be able to determine, identify and evaluate whenever a nonconformance, which must identify the need of operator training.

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