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IV Pan American Conference on Drug Regulatory Harmonization Dominican Republic March 2 – 4, ... - page 9 / 15

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Chapter 8: Documentation

Batch Process Record

The following information should be recorded at the time each action is taken, and after completion the record should be dated and signed by the person responsible for the processing operations:

Name of the product, batch number

Dates and times for major steps in process

Name of person responsible for each stage of production

Name of operators carrying out each step (check signatures)

Theoretical quantities for materials in the batch

Reference number and quantity of materials used in the batch

Main processing steps and key equipment

In-process controls carried out, and results obtained

Yield at each stage with comments on deviations

Expected final yield with acceptable limits

Comments on any deviations from process.

Area clearance check, instructions to operators

Record of activities

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