Retention Period: 7 Years
Policy Number: MURR-001-007
Includes records listed below, only where other sections of this retention are not applicable, does not include any training records or records of radioactive materials handling or transfer.
- Batch-related and Study-related records:
- Raw data, training, equipment, information protocols, QA documents, 1 year after approval of the application to which they are related 21 CFR 211.180
- Production, control or distribution, 1 year after expiry date of the batch 21 CFR 211.180
- Components, drug product containers, closures and labeling, including records relating to examination, inventory, and disposition of rejected materials 21 CFR 211.180 and 21 CFR 211.182
- Program-related records:
- Data derived from tests performed to ensure compliance with specifications and standards, including testing and standardization of laboratory reference standards, reagents, and standard solutions 21 CFR 211.194
- Modifications of an established test method, including the reason(s) for the modification and data to verify the accuracy and reliability are acceptable 21 CFR 211.194
- Calibration and maintenance of laboratory instruments, gauges, and recording devices 21 CFR 211.194
- Stability testing 21 CFR 211.194
- Inspection or audit reports and associated documentation
- Records relating to purchasing, examination, and inventory of materials and disposition of rejected materials
- Records of nonconforming work, complaints, and corrective actions
- Series Cutoff: Date of Creation
- Disposition Action: Securely Destroy or Delete
- Notes and Citations: Assess and Destroy/Delete if eligible for destruction
- Batch-related records: Retain for seven (7) years, unless otherwise required by a contract or agreement with a customer, an FDA submission, including a research or marketing permit, Investigative New Drug (IND), Abbreviated New Drug Application (ANDA) or Drug Master File (DMF). After seven (7) years, reevaluate for further retention.
- Program-related records: Retain for the life of the related product plus seven (7) years, then reevaluate for further retention. Batch records must be kept on-site during full term of retention period for use of FDA inspectors per 21 CFR 211.180. Destroy or transfer to appropriate retention category.