SIDE NOTES:

MASTER BATCH PRODUCTION RECORD:

1. General information describing the product and the type of packaging material to
be used or its alternative, statement of the product stability, safety precautions
during storage and other precautions to be taken during processing and
packaging of the product.
2. Product composition or formula for one dosage unit as well for the sample.
3. Complete list of raw materials whether they remain unchanged or become
altered during process
4. Reference to the specification of raw materials
5. Complete list of packaging materials.
6. Reference to the specification of packaging material
7. Processing and packaging procedures
8. List of equipment which may be used for processing and packaging
9. In-process control during processing and packaging
10. Product shelf-life