1. After the SOP is produced, it must be confirmed by quality assurance and then confirmed by the biotechnology supervisor. (Except for the producer, the signature part cannot be printed by computer).

2. Each model of SOP must have a version LIST to indicate the latest SOP version of the model at each workstation at that time.

3. There must be a record of changes to the SOP of the model, including a list of all changes to all SOPs of the model.

4. The SOP issued by the manufacturing unit must use "A3" size paper and the quality assurance unit must use "A4" size paper, and both must be signed for.

5. All SOPs must be printed out and saved, and all electronic documents must be backed up.