1. Preparation before production: including preparation of production equipment, raw materials and personnel.
2. Production process: including information on all aspects of drug production, such as preparation, cleaning and sterilization of raw materials, manufacturing, packaging and quality control of drugs.
3. Inspection records: including various inspections in the pharmaceutical production process, such as raw material inspection, intermediate product inspection, finished product inspection, etc.
4. Abnormal handling records: handling measures and results in case of abnormal phenomena or problems in the production process.
5. Product release records: including various indicators of drug quality control, such as physical and chemical indicators and microbial indicators, as well as evaluation and confirmation of drug quality.
6. Signature and approval: All personnel involved in production, inspection and quality control shall sign the batch production records and be approved by the competent person.