Pharmaceutical Good Manufacturing Practice Regulations Article 48

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.