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Cleaning Validation Glossary

Equipment Cleaning Record (ECR)

Records the major cleaning of equipment

ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients section 6.2 requires a written record of major equipment cleaning. This record is reffered to as the equipment cleaning record (ECR) and includes the date, time, product, batch numbers, and persons who performed the cleaning activity. The ECR serves as the physical instruction that operators follow on the manufacturing floor to guide the cleaning of the equipment. Critical details such as time, concentrations and amounts of cleaning agents used, cleaning technique details, and temperatures should be included so that the cleaning process is consistent between operators. The ECR is written following the associated equipment cleaning standard operating procedure.

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