Records

Records Check

Control Records

• Maintenance of control records for:

  • Raw materials and primary packaging materials

    • Documenting disposition of rejected materials.

  • Manufacturing of batches

    • Documenting kinds, lots, and quantities of material used.

    • Processing and handling of materials:

      • Transferring, holding, and filling.

  • Operations

    • Sampling, controlling, adjusting, and reworking.

  • Code Marks

    • Documenting code marks of batches and finished products.

Finished Products

• Documentation includes:

  • Sampling

  • Individual laboratory controls

  • Test results

  • Control status.

Distribution

• Documenting:

  • Initial interstate shipment

  • Code marks and consignees.