Part 2 Good Manufacturing Practices for Pharmaceuticals
Chapter 2 Good Manufacturing Practices for Chinese Herbal Medicines
Section 11 Records and Reports
The manufacturing, control, shipping and sales records prescribed in Chapter 2 shall all be stored in suitable locations, made available for inspection, and used at least once a year in the assessment of product quality standards; aforesaid records shall be kept until one year after the expiration date of the batch of products or end products in question. However, records for products that do not require expiration dates shall be kept for three years after the date of dispatch of the batch of products or end products in question.
When relevant competent authorities make inspections, they may photocopy, or copy by other means, the records described in Paragraph 1 or copies of aforesaid records.
Chinese herbal medicine factories shall keep batch manufacturing records for each batch of products produced; aforesaid records shall contain comprehensive manufacturing and quality control information on the product batch in question.
Chinese herbal medicine factories shall produce accurate copies of manufacturing management standards, verify the accuracy of aforesaid copies, and sign and date them.
Chinese herbal medicine factories shall make detailed records of the important steps in the manufacture, processing, re-packaging, packaging and storage of each batch of products; aforesaid records shall include the following items:
(1) Date and product batch number;
(2) Identification marks for each batch of raw materials and semi-finished or intermediate products;
(3) Identity of major facilities and production lines;
(4) Quantity and volume of raw materials used in product processing;
(5) Manufacturing process, testing and control results;
(6) Pre- and post-use inspection of labeling and packaging areas;
(7) Ratio of actual production output to theoretical output at appropriate stages of manufacturing process;
(8) Comprehensive labeling control records, including samples or copies of all labeling;
(9) Product container and cap identification marks and usage quantity;
(10) Sampling record;
(11) Dates and times of each major step in the production process, as well as signatures and dates for operation personnel, direct supervisors or inspectors involved in each step.
The test records produced by Chinese herbal medicine factories shall include all test data used in determining compliance with established specifications and standards; aforesaid data shall include the following items:
(1) Sampling location, quantity, batch number or other clear identifying code, sampling date, and date of test completion;
(2) Basis of all test methods;
(3) Weight or volume of all samples tested;
(4) Comprehensive records of all data generated during testing process, including charts, graphs and spectra produced by test instruments, and clearly listing all the raw materials, product containers, caps, semi-finished products, intermediate products or products tested, along with the batch numbers of aforesaid items;
(5) Record of all test-related calculations;
(6) Records of test results and comparison of aforesaid results with established specifications;
(7) Names and dates for all personnel involved in conducting tests;
(8) Signatures of inspectors testifying that the original records inspected are accurate, truthful and in compliance with established specifications.
The manufacturing and quality control records (including packaging and labeling control records) for all products manufactured by Chinese herbal medicine factories shall be examined by the quality control departments of aforesaid factories to ensure that all products are in compliance with all established documented operational procedures prior to release, shipment or sale.
Where the theoretical production quantity exceeds the upper or lower production quantity limits prescribed by manufacturing control standards, or if any other similar discrepancy occurs, or if any batch or raw material does not conform to specifications, a thorough investigation shall be conducted even if aforesaid batch of products has already been shipped or sold; such investigations shall be extended to other batches of the product in which aforesaid discrepancy occurred, and to any other products that may be affected by aforesaid discrepancy.
Written records shall be kept of the investigations described in the preceding Paragraph; aforesaid records shall include investigation conclusions and methods.
Chinese herbal medicine factory’s shipping and sales records shall include products names, contents, dosage forms, recipient names and addresses, and shipping dates and quantities.
Chinese herbal medicine factories shall make written records of product complaints, and keep aforesaid records in product complaint files; aforesaid files shall be stored in a suitable location, or in a facility where they can be easily accessed for inspection.
The written records referred to in the preceding Paragraph shall be kept until the expiration date of the product in question, or for one year after the complaint was received, whichever period is longer. However, for products that do not require expiration dates, aforesaid records shall be kept for at least three years after the date of dispatch of the product in question.
Records of returned products kept by Chinese herbal medicine factories shall include product names, contents, batch numbers, reasons for return, quantities, disposition dates, final disposition methods; aforesaid records shall be kept in accordance with the regulations prescribed in Article 81.