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Jason@cleanroomequips.com
1. Purpose
Establish regulations for personnel control and management in clean areas of pharmaceutical factories, strengthen and standardize the hygiene requirements of clean area staff, prevent irregular behaviors from causing pollution to products and the environment, ensure that products are produced in clean areas with corresponding cleanliness, and ensure product quality.
2. Scope
Applicable to all staff entering the clean area.
3. Basis for formulation
"Pharmaceutical Production Quality Management Standards (Revised in 2010)" and related documents.
4. Specific requirements
Individuals should take a bath, have a haircut, shave, trim their nails, change clothes, keep themselves clean, and develop good hygiene habits. Smoking and eating are prohibited in production areas and storage areas. Non-production items such as food, beverages, cigarettes and personal medicines are prohibited. Food or food packaging cannot be brought into the production area. Valuables (mobile phones, wallets, etc.) should be stored in personal work cabinets for safekeeping. Mobile phones are prohibited in clean areas.
When entering the clean area, you must strictly follow the dressing procedure to change clothes:
Change shoes (shoes in different areas are placed in corresponding positions according to regulations) → wash hands and disinfect → wear clean tops and pants, shoe covers (first on and then off), wear masks (after putting on, tidy up your clothes in front of the mirror to ensure that your hair, beard and clothes inside are not exposed) → enter the buffer room and disinfect your hands → clean area When entering and leaving the clean area, you should close the door at will, and you cannot open the passage connecting the buffer room and different clean levels at the same time to avoid affecting the circulation of Clean air in the clean area. Avoid loud noises when working in the clean area, and prohibit fighting and playing; operations should be handled with care, and the materials in the scale must be reviewed by a second person. After the materials are placed in the scale, the work surface should be cleaned in time to keep the work area clean and tidy at all times.
It is necessary to strengthen the maintenance of production equipment, lubricate the rotating parts of the equipment in a timely manner, check the circuit and check and replace the easily worn parts, etc. It is forbidden to knock or deliberately damage the equipment.
The tools and cleaning utensils used for production should be classified and stored at fixed points. Cleaning utensils and rags cannot be cross-mixed. After use, they should be cleaned and stored in the sanitary room. Tools should be placed in the specified position, cleaned and put back to the original position in time after use, and the production area should be kept clean and orderly at all times. All kinds of records used in production should be placed and classified in obvious places at the post, so that the staff can record the operation content in time and review it. After the production is completed, the batch records shall be sorted by the post personnel, and the person in charge shall review and submit them to QA for archiving.
When using the water, gas and steam of the public system, each post should use them reasonably in the spirit of saving. After use, the valves shall be closed in time or the engineering department shall be notified to close the pipeline switch to prevent waste.
After the production of each workstation is completed, the production area environment shall be cleaned and cleared in time. After the inspector confirms that the cleaning is qualified, you can leave the clean area. Try not to stay in the clean area to reduce the number of people in the clean area and prevent too many unnecessary people from affecting the air quality and environment of the clean area, thereby causing pollution and cross-contamination of the product. Each employee shall supervise each other on the implementation of the above regulations. The production manager, workshop directors and QA shall supervise, spot-check and record the implementation of the regulations. Those who violate the regulations shall be subject to different degrees of education, criticism or punishment by the human resources department.
The specific violations are categorized as follows:
| Bringing food, mobile phones and jewelry into the production area | Category A |
| Not changing clothes and disinfecting according to the prescribed procedures when entering and leaving the clean area (shoes should be neatly placed in the prescribed shoe cabinet, and general area clothes and hats cannot be taken off at will in the production area) | |
| Wearing work clothes, work shoes, and hats, and leaving the workplace. | |
| Loud noises, quarrels, and idle chatter in the clean area during working hours | |
| Leaving work stations, visiting other posts, reading books, eating, or doing private work during working hours | |
| sleeping on the floor of the clean area in work clothes | |
| not clearing the area in a timely manner as required (or clearing the area in a perfunctory manner) | |
| Failure to timely fill in batch production records, inspection records, instrument use records, etc., as well as alteration and destruction of original records | |
| Damage to the floor in the clean area and waste of process water | |
| Sleeping at work, passive slacking or not working hard | Category B |
| Failure to follow SOP or unauthorized changes to operating methods, failure to monitor important process parameters in a timely manner, etc., which may affect product quality and quantity | |
| Failure to operate equipment in accordance with regulations, resulting in equipment damage and affecting production progress | |
| Failure to complete relevant verification, training and other related work in a timely manner |
Related Information
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