We are a manufacturer of proprietary Chinese medicines. What are the testing requirements for raw materials (Chinese herbal medicines) in routine production?

As a licensed manufacturer of proprietary Chinese medicines, quality control of raw materials is the first step in ensuring the safety and efficacy of the finished product, and is a core GMP requirement. Each batch of Chinese herbal medicines purchased must be rigorously tested before being used in production. The tests must include at least: 1. Identification of origin, confirming that the species is correct and that there is no confusion or adulteration. 2. Macroscopic examination, using traditional methods such as visual inspection, touch, smell and taste to check whether the appearance, colour and odour of the medicines conform to pharmacopoeial standards. 3. Microscopic identification, where necessary, using a microscope to examine the tissue structure of the medicines. 4. Physicochemical identification, including tests such as thin-layer chromatography (TLC), with comparison against the chromatogram of the relevant reference standard. 5. Safety testing for harmful substances such as heavy metals, pesticide residues and aflatoxins, to ensure that their levels are within statutory limits. All testing must be supported by detailed records and reports.