Pharmaceutical Good Manufacturing Practice Regulations Article 43

Specifications, standards, sampling plans, test procedures, and test control measures established for the various departments of a Chinese herbal medicine factory, and any alterations related to aforesaid items, shall be examined and approved by the quality control department of aforesaid factory prior to implementation.Chinese herbal medicine factories shall faithfully follow the operational guidelines that they have established and keep records of the implementation process; where a deviation from aforesaid guidelines occurs, aforesaid deviation shall be recorded, a determination of how best to handle the deviation shall be made, and an explanation shall be given.Chinese herbal medicine factories shall select senior specialist personnel from each department to establish a quality assurance team or committee to advice, review and supervise activities related to quality system.