Part 2 Good Manufacturing Practices for Pharmaceuticals
Chapter 2 Good Manufacturing Practices for Chinese Herbal Medicines
Section 8 Management of Packaging and Labeling
Article 36
Chinese herbal medicine factories shall establish in writing management procedures for the acceptance, labeling, storage, handling, sampling and testing of packaging and labeling materials.
Where over-the-counter drug products for human use are produced, packaging for aforesaid products shall be tamper-proof, and shall be kept intact during the manufacturing, shipping and retail display process; moreover, aforesaid packaging shall be designed in such a manner that tampering is easily detectable by consumers.
Prior to the acceptance or use of labeling and packaging materials, representative samples shall be taken from each batch for testing; testing results shall be recorded and samples preserved. Where test results comply with established specifications, aforesaid materials may be approved for use; where aforesaid materials are not in compliance, they shall not be approved for use.
Article 37
Chinese herbal medicine factories shall, in accordance with product type, content and dosage form, separately store and appropriately mark labels and other labeling materials; storage areas for aforesaid materials may not be entered without the consent of the personnel in charge.
Packaging or labeling materials that have expired or are not approved for use shall be returned or destroyed. The amounts of labeling materials received, used and returned shall be kept track of, and no discrepancies shall be allowed.
Unused portions of labeling materials printed with batch numbers shall be destroyed; unused labeling materials that are not printed with batch numbers shall be appropriately identified and stored.
Article 38
Prior to packaging and labeling products, Chinese herbal medicine factories shall first inspect packaging and labeling materials to ensure that they are correct and suitable for use; aforesaid inspection results shall be entered into the batch manufacturing record.
Packaging and labeling facilities shall be inspected prior to use to ensure that all pharmaceuticals from the previous run and packaging and labeling materials not suited to the present run have been completely removed; aforesaid inspection results shall be entered into the batch manufacturing record.
During the final stage of production, products that have already been packaged and labeled shall be inspected to ensure that every container or package is correctly labeled.
Article 39
To ensure that the ingredients, contents, quality and purity of products ready for use are in compliance with established specifications, Chinese herbal medicine factories shall, unless other regulations apply, label aforesaid products with a usage period or expiration date as determined through stability testing; products that must be prepared before use shall be clearly labeled with the method of preparation and usage period following preparation.