Part 2 Good Manufacturing Practices for Pharmaceuticals
Chapter 2 Good Manufacturing Practices for Chinese Herbal Medicines
Section 10 Quality Control
Chinese herbal medicine factories shall establish in writing quality department duties and operational procedures; aforesaid duties and procedures shall include the following items:
(1) Examination of approval, non-approval and manufacturing records for all raw materials, product containers, caps, semi-finished or intermediate products, packaging materials, labeling materials and products;
(2) Examination of operational procedures specifications that affect product ingredients, contents, quality and purity;
(3) Inspection of facilities used in the testing of raw materials, product containers, caps, semi-finished or intermediate products, packaging materials, labeling materials and products;
(4) Establishment in writing of operational procedures governing the calibration of instruments, devices, meters and recording apparatuses; aforesaid procedures shall clearly prescribe calibration methods, schedules, accuracy limits, as well as usage restrictions and remedial measures for items that do not comply with accuracy limits;
(5) Establishment in writing of operational procedures governing sample quantities, test intervals and test methods for product stability testing.
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.
Chinese herbal medicine factories shall test every batch of products to ensure that they are in compliance with established specifications; each batch of products that must not contain harmful microorganisms shall, where necessary, be subjected to appropriate tests.
Representative samples shall be removed from each batch of products or end products, and taken from the raw materials containing active ingredients used in making aforesaid products, and placed in reserve; aforesaid reserve samples shall be stored under indicated conditions, and shall be of at least twice the quantity needed for all required tests.
Reserve samples shall be retained until one year after the expiration date of the product from which it was taken; reserve samples of products that do not require expiration dates shall be kept for at least three years after the date of dispatch of the last batch of aforesaid product.