Management Specification For Solid Preparation Workshop In Pharmaceutical Production Enterprises

In order to ensure product quality and reasonable and orderly production, according to the company's GMP document and the actual situation of the clean area, ensure the production area of the clean area meets the requirements, and make the following management and punishment regulations:

1, enter the clean area personnel before going to work every day, according to the "personnel entering and leaving the clean area and changing the rules of operation" for proper dress and personnel purification, shoes in the shoe department, in the dressing room according to the requirements of hand washing, disinfection, wearing clean clothes, cap and masks; when leaving the clean area, we must change clothes and shoes in accordance with the procedures of the wearing process, and put the work clothes in the locker, work shoes in a more shoe cabinet; after work, put dirty clothes into the closet bucket, and close the door with hands, and the violator fines 5 yuan / time.

2, non production goods and personal debris shall not be brought into the production area, smoking, chewing areca and eating food in the production area shall not be allowed; activities not related to production shall not be allowed; the offender shall be fined 5 yuan / time.

3. The operators in the cleanliness area shall wear the required labor insurance articles on duty as required. Before the production, they must fill in the status sign (including the product name, batch number, operator and production date) in the production operation room, and the operator who has not completed the status sign in time will pay a fine of 5 yuan / time.

4, the abnormal situation in the production process should be reported to the technician or workshop director in time. It can not be handled or concealed privately. Offenders are punished according to the circumstances.

5. In the production process, the operation must be stable, accurate and light. The powder (capsule and film) dropped to the ground should be cleaned in time, and the production site should be kept clean and tidy, and the situation will be severely fined 5 yuan / time.

6, clearing work is the main content of the daily work of each post.

(1) small farms: daily production must be carried out before going to work. The waste produced in the production process should be cleaned up in the plastic bucket in the operating room in time. The cleaning area will be cleared out in time according to the regulations after the completion of the clearance. The area in charge of each process must be cleared before going to work, and the operator shall be fined 5 yuan per time.

(2) Daqing Farm: large clearing sites must be carried out before replacement of varieties, including clean floor drain and disinfection with disinfectant. After operation, there is no last production residue in operation rooms, equipment and containers, and there is no water on the ground, and the waste in production is clear away from the clean area.

7. During the batching process of the product, according to the actual production prescription of the existing product, the production line should be put into production. When the weight of the material entering the intermediate station is seriously deviated, the intermediate station administrator must report to the technician or the workshop director in time. After the reason is found out, the corresponding punishment should be made according to the situation.

8. The middle station administrator should clean the middle station every day, keep the materials and floors clean and tidy, and fill in the "intermediate station material ledger", and keep the door of the intermediate station closed.

9, the operation area or delivery window in each area responsible for each process in the clean area must be closed, and the team in the violation shall be fined 5 yuan / time, and be punished by its monitor.

10, the public health personnel should clean the public health walkway every day, keep the aisles, changing rooms and shoes cabinet clean and clean, and the penalty is 5 yuan / time.

11, material must be filled in the process of production and circulation, and fill in the product name, batch number, weight, operator and date. The offender will be fined 5 yuan / time.

12, the process of each team must fill out production records and auxiliary records as required, and hand it to workshop technicians in time, and the offender will be fined 5 yuan / time.

13, operators of posts should not string posts, and the offenders will be fined 5 yuan / time.

14, the operators must check the operating rooms before going off duty, strictly prohibit long running lights, ask people to turn off the lights, and the offenders will be fined 5 yuan / time.

15, all the operators in the work time prohibit the working hours, loud noise, sitting on the ground, violators fines 5 yuan / time.

The leader of the process team is the organizer and executor of the on-site management of the responsible area, who is responsible for the overall arrangement of the field management work in the area. A working diary is recorded in each process group. The monitor records the daily production situation and the production site conditions. The workshop QA, the technician, the workshop director and the production minister carry out inspection records on the execution of each team. The record is the important basis for team assessment. The on-site management level of each team is directly linked to the class allowance, and the team leader performs monthly assessment. The team members of their team are 3 months low, and the squad leaders of their teams will be punished according to the circumstances. Clean areas

Editor in chief: Du Jun