Equipment and Room Use and Cleaning Log

Equipment and Utensils (Part D) cGMP SOP Templates and Supporting Documents

Equipment and Room Use and Cleaning Log

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Published: Thursday, April 1, 2010

A form such as this may be used to document the use and cleaning of equipment which is permanently located in a particular room. It is critical to record each product and lot for which a piece of equipment or room is used, in chronological order, so that if problems arise there is a way to investigate whether previous or subsequent batches were also affected and/or whether cross contamination occurred. Companies will want to optimize the form as appropriate for their operations. “Use start time” and “Use finish time” may not be applicable to all operations. Cleaning SOP references are especially useful if multiple cleaning SOPs exist for the same equipment or room. In lieu of an SOP reference, space may be provided to record the cleaning/sanitizing agent(s) used and their concentrations. Space may also be provided to record cleaning effectiveness checks (visual examination or swabs). It is optional to assign a cleaning expiration date, but these may be useful in case the equipment or room is not used for an extended period of time, in which case re-cleaning may be appropriate. The form may be modified to document equipment use and cleaning alone (separately from a specific room), and/or room use and cleaning alone (separately from any piece of equipment).

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