A, batch production records and their preservation period requirements

1. Requirements: Batch production records shall be legible, true in content and complete in data, and signed by operators and auditors. Records shall be kept clean and tidy, and shall not be torn up or altered at will; When making changes, sign the changes and make the original data still recognizable.

2. Shelf life: The batch production records shall be filed according to the batch number and kept for one year after the expiry date of the drug. Batch production records of drugs without expiry date shall be kept for at least three years.

Two, production operations should take measures to prevent drug pollution and confusion.

1. Before production, it shall be confirmed that there is no residue from the last production;

2. The generation and diffusion of dust should be prevented;

3. Production operations of different product varieties and specifications shall not be carried out simultaneously in the same production operation room; When several packaging lines are packaged at the same time, isolation or other effective facilities to prevent pollution or confusion should be adopted.

4. In the production process, cross-contamination caused by gas, steam, spray or organic matter generated by materials and products should be prevented;

5. Each production workshop or production equipment and container shall indicate the name, batch number and quantity of the products or materials produced;

6. Selected medicinal materials should be washed with tap water, and used water should not be used to wash other medicinal materials. Medicinal materials with different medicinal properties shall not be washed together. Washed medicinal materials and processed products should not be dried in the open air.

Three. Contents of batch packaging records

1. Name, batch number and specification of the product to be packaged;

2. The label has batch number, instruction manual and product certificate;

3. The number of products and packaging materials to be packaged and the signatures of the issuer, receiver and auditor;

4. Number of packaged products;

5. The previous packaging job site cleaning record (copy) and the current packaging site cleaning record (original);

6. The inspection and verification results after the completion of the packaging operation, and the signature of the auditor;

7. Signature of the person in charge of production and operation.