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IV Pan American Conference on Drug Regulatory Harmonization Dominican Republic March 2 – 4, ... - page 10 / 15

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Chapter 8: Documentation

Packaging

Packing instructions

Name of the product

Dosage form, strength and method of administration

Pack size (number, weight or volume of product in finished pack)

List of all packaging materials (quantities, size and code number)

Examples of printed packaging materials, with location of batching information

Special precautions, including area clearance checks

Description of the packaging operation

In-process control checks, with sampling instructions and acceptance criteria

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