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Records and Reports

There is a saying that is probably familiar to most laboratory professionals, "If you didn't write it down, you didn't do it." Records of each critical step in the process of manufacturing is essential. Part 211 Subpart J describes general record keeping requirements, including the following:
  • Records need to be maintained of component manufacturing.
  • Records must be available at the time of inspection and must include these records
    • Reviews of complaints
    • Recalls
    • Returned or salvaged drug (blood) products
    • Investigations conducted
    • Notifications of responsible officials of the firm of any recalls and inspection deviations
  • Equipment cleaning and use logs
  • The identity and quantity of each shipment
  • The results of any test or examination performed
  • The disposition of rejected components
  • Master production and control records
  • Batch production and control records
  • Production record review
  • Laboratory records
  • Distribution records
  • Complaint files
Both Sections 600.12 and 606.160 require contemporaneous record keeping. In other words, the record needs to be made at the time the function is performed. In addition, these sections list a multitude of records that must be kept.
600.12 also defines the period of record retention to be at least 5 years. This differs from other sections of the laboratory where record retention is usually 2 years.