The requirements for the original records of drug inspection are: truthfulness, completeness, clearness and signature of the inspector.

Basic requirements for recording:

1. Original inspection records should be written in blue-black ink or carbon pen (pencil can be used for microscopic drawing). All data and maps printed by microcomputer should be cut and pasted in the appropriate place on the record, and signed by the operator; If the data is printed on thermal paper, the main data should be recorded on the recording paper with blue-black ink or carbon pen to prevent it from fading for a long time and being difficult to identify.

2. Before inspection, inspectors should pay attention to whether the label of the inspection product is consistent with the contents of the inspection form, and check the serial number, product name, specification, batch number and expiration date, production unit or place of origin, inspection purpose, and the number and packaging of samples one by one.

3. In the inspection record, the basis of inspection should be stated first. Where according to the China Pharmacopoeia, the Ministry (bureau) issued standards, should list the standard name, version, number of pages or standard approval number. ?

4. During the inspection, each inspection item can be recorded in the inspection order, including: item name, inspection date and operation method (if it is completely in accordance with the method contained in 3 inspection basis, it can be briefly described; However, if it is slightly modified, all the changed parts should be recorded), experimental conditions (such as experimental temperature, instrument name and model, calibration, etc.),

observed phenomena (do not copy the standard, but briefly record the real situation observed during the inspection; In case of abnormal phenomena, it should be recorded in detail and clearly marked for further study), experimental data, calculation (please pay attention to the revision and operation of effective figures and values, for details, see page 45 of China Standard Operating Rules for Drug Inspection) and result judgment, etc.

all records shall be made in a timely and complete manner, and it is strictly forbidden to make up or copy afterwards. If the record is found to be wrong, it can be crossed out with a single line and the original handwriting can be argued, and it is not allowed to be erased or altered; And should sign or seal the amendment to show responsibility. Inspection or test results, regardless of success or failure (including necessary retest), shall be recorded and saved in detail.

the possible causes of discarded data or failed experiments should be analyzed in time and noted on the original records.

5. The source, batch number and treatment before use of the standard substance, reference substance or reference medicinal materials used in inspection shall be recorded; For content (or titer) determination, the content (or titer) and loss on drying (or moisture) shall be indicated.

6. Each inspection item shall specify the limit or scope specified in the standard, and make a single conclusion (whether it meets the requirements or not) according to the inspection results.

7. After the whole inspection work is completed, the inspection records should be numbered page by page in sequence, and a clear conclusion should be made on this inspection product. After the signature of the inspector, the personnel designated by the person in charge of the quality inspection institution shall check and sign the adopted standards, standardization of operation, calculation and judgment of results; Then report it after being audited by the person in charge of the quality inspection agency.