PH35 QUALITY INVESTIGATIONS SOP Template

Pharmaceutical Standard Operating Procedure Template- Describes the procedure for documenting an exception report. This is a failure to meet predetermined material, product, process, facilities, equipment or system requirements or an observation or a trend that could potentially affect product quality. In addition, the exception report may require further action, a quality investigation and/or further action. Package consists of the procedure, an Exception Report, a Quality Investigation Checklist and an Exception Log.