Part 2 Good Manufacturing Practices for Pharmaceuticals
Chapter 2 Good Manufacturing Practices for Chinese Herbal Medicines
Section 12 Handling of Complaints and Returned Products
Chinese herbal medicine factories shall establish in writing procedures for the handling of oral and written complaints from consumers; all oral and written complaints shall be investigated and assessed by the quality control departments of aforesaid factories.
Where Chinese herbal medicine factories discover serious and unanticipated product defects, they shall report aforesaid defects to the relevant competent authorities, and handle aforesaid defects in accordance with the stipulations of the Act.
Written records shall be kept of the handling of all complaints; aforesaid records shall be properly collated and filed.
Chinese herbal medicine factories shall properly identify and separately store returned products. If there are any doubts regarding a product’s safety, ingredients, contents, quality or purity due to storage or shipping conditions, the condition of the product, container, packaging or labeling, or any other relevant circumstances either before or after the product is returned, unless the product’s safety, ingredients, contents, quality and purity are confirmed to be in compliance with established specifications through testing or investigation, aforesaid product shall be destroyed. However, where aforesaid product can be brought into compliance with established specifications through remanufacturing, remanufacturing may be carried out.