Pharmaceutical Good Manufacturing Practice Regulations 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.