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IV Pan American Conference on Drug Regulatory Harmonization Dominican Republic March 2 – 4, ... - page 8 / 15

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Chapter 8: Documentation

Master Formula

The master formula should include:

Name of  product with product reference code

Dosage form, strength and batch size

Full list of materials including quantities; unique reference code

Expected final yield with acceptable limits (+intermediate yields)

Processing location and principle equipment

Equipment preparation methodology

Stepwise processing instructions

Details of in-process controls with instructions for sampling and acceptance limits

Storage requirements and special precautions

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