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CURRENT GOOD MANUFACTURING PRACTICE (cGMP) PRODUCTION, PACKING AND LABELING DOCUMENTS FOR APIS AND FINISH DRUG PRODUCTS, GOOD LABORATORY PRACTICE (GLP/ISO/IEC 17025) PRODUCTION AND QUALITY DOCUMENTS

Series #: MURR-001-007

Series Description:

  • 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.
    • A.  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
    •  B.  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

Retention Period: 7 Years

Disposition Action: Securely Destroy or Delete

Approval Date: Pending

Notes and Citations:

Assess and Destroy/Delete if eligible for destruction

A.  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. 

B. 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.

 

Reviewed 2025-05-01