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IV Pan American Conference on Drug Regulatory Harmonization Dominican Republic March 2 – 4, ... - page 11 / 15

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Chapter 8: Documentation

Batch Packaging Records

Name of the product, batch number and quantity to be packed

Batch number, theoretical quantity and actual quantity of finished product

Reconciliation calculations, dates and times of operation

Name of person responsible for packaging, initials of operators carrying out each step

Checks made and results obtained

Details of packaging operation, including equipment and line used

Returns to store

Specimen of printed packaging materials, with batch coding

Comments on deviations from the process and actions taken

Reconciliation of packaging materials, including returns and destruction

Area clearance check

Product variables

Record of activities and check signatures

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