What are the requirements for the GSP Certified Acceptance Care Room? How does the device inside wor

1. Acceptance and maintenance room management regulations 1Personnel should be strict with themselves, and take care of all facilities and items in the acceptance and maintenance room. The acceptance and maintenance room should be kept quiet and tidy.

2.The laboratory utensils should be cleaned in time after use, and the excess reagents should not be poured back into the original bottle to avoid contamination. Reagents or utensils should be returned to the place of return after use.

3.All kinds of instruments are kept by the conservator, who is responsible for the maintenance and maintenance of the instruments. 4.

Before using various precision instruments, it is necessary to read and learn the instruction manual or standard operating procedures of the instrument, and can only be used after training. After use, clean and maintain the instrument, return the accessories to the place after inventory, and finally fill in the use registration. 5.

The original record should be filled in on the record during the inspection, and it should not be temporarily copied on other pieces of paper or notes. 6.Personnel from other units are not allowed to enter the acceptance and maintenance room without permission.

Second, the acceptance of the maintenance room operating regulations 1Acceptance of the safe operation of the curing room Before the inspection, you must be familiar with the operating principle and precautions of the equipment, and check whether the installation of the equipment and instruments is in good condition. The spirit of the inspection should be concentrated, no chatting with others, and it is forbidden to leave the job during the operation.

Corrosive and irritating substances should not be directly touched by hand, and tools should be used. 2.The management of the equipment and instruments in the acceptance and maintenance room shall be carried out in accordance with the relevant requirements.

3.Acceptance of the maintenance room of the sanitation of the acceptance of the maintenance room to strictly control the entry of personnel, non-room personnel are not allowed to enter without permission. Before entering the acceptance and maintenance room, you should change your shoes and keep the acceptance and maintenance room clean.

The acceptance and curing room should be controlled with temperature < 30 and relative humidity 45-75% to protect the instrument. The acceptance and maintenance room should keep the windows and walls clean, the ground smooth, flat and clean, no stagnant water, no debris, and dust-proof and insect-proof ventilation facilities. The staff of the acceptance and maintenance room strictly follow the requirements of the "Health and Safety Management System".

Personal daily necessities are not allowed to be brought into the acceptance and maintenance room. 4.Management of inspection records The management of inspection records is strictly implemented in accordance with the relevant requirements of the "Records and Voucher Management System".

There should be a record after the operation of the instrument. 5.Use of chemical reagents Check whether the packaging of the reagents used is in good condition, whether the appearance of the reagents meets the requirements, and whether the reagents are within the specified validity period.

Check that the operating equipment used is clean. Before use, identify the name of the reagent, its concentration, and whether it is within the expiration date. Pay attention to protect the bottle label when using it to avoid spilling the reagent on the bottle label.

Pay attention to safety during use. After use, return to its original place to prevent undue errors caused by disorder.

GSP certification for the acceptance of the setting and requirements of the maintenance room:

1. Pharmaceutical wholesale and retail chain enterprises should set up an acceptance and maintenance room in the warehouse, and the area of the acceptance and maintenance room: Large enterprises shall not be less than 50 square meters; Medium-sized enterprises are not less than 40 square meters; Small businesses are not less than 20 square meters.

2. Equipment requirements The acceptance and maintenance room should have the necessary moisture-proof and dust-proof equipment. If there is no drug testing room in the warehouse or the instruments and equipment cannot be shared with the laboratory, it should be equipped with a thousandth balance, clarity detector, standard colorimetric solution, and moisture analyzer, ultraviolet fluorescent lamp, dissecting mirror or microscope for dealing in Chinese herbal medicines and Chinese medicine decoction pieces.

How to operate these equipment, I can't teach you here, you can only go to the relevant units to learn, or invite someone to your company to teach you, not in a moment and a half can learn.

Note: Large enterprises refer to annual sales of more than 10 million, medium-sized enterprises refer to annual sales between 500 and 10 million, and small enterprises refer to annual sales of less than 5 million.

The drug acceptance and maintenance room involved in GSP certification refers to the acceptance and storage maintenance inspection of drugs, which need to use some simple instruments and equipment to inspect the appearance of the drug, and the place where these instruments and equipment are stored and inspected is the acceptance and maintenance room.

The laboratory usually refers to the place where the intrinsic quality indicators of drugs are tested, which is often referred to as the laboratory. At present, GSP no longer requires a laboratory.

The difference between the drug curing room and the laboratory is simply that the curing room is mainly for visual inspection, and the laboratory is mainly for internal quality inspection.