The color standard of drug quality status is:
Qualified drugs-green; Unqualified drugs-red; Drugs with unknown quality-yellow.
According to the actual needs of warehouse management, the unified standards for color coding of warehouse management areas are: the drug warehouse (or area) to be tested and the drug warehouse (or area) to be returned are yellow; Qualified drug storehouses (or areas), Chinese herbal pieces called taking storehouses (or areas) and drug storehouses (or areas) to be prepared are green; Unqualified drug warehouse (or area) is red. Three-color signs should be based on the background color, and the text can be expressed in white or black to prevent color code confusion [1].
(2) Handling and stacking requirements
We should strictly abide by the requirements of the schematic signs of drug packaging and standardize the operation. The stacking height of drugs that are afraid of pressure should be well controlled to prevent the packaging box from being squeezed and deformed. Drugs should be stacked relatively centrally and separately according to varieties and batch numbers. Drugs of different varieties or different batches of the same variety shall not be stacked together to prevent accidents of wrong hair and mixed hair.
(3) Drug stacking distance
There should be corresponding spacing or isolation measures between the floor, wall, ceiling and radiator between the drug stack and the warehouse, and a goods passage with sufficient width should be set to prevent the facilities in the warehouse from affecting the quality of drugs and ensure the effective development of storage and maintenance management. The distance between the medicine stack and the wall, roof (beam), radiator or heating pipe in the warehouse and the ground should be not less than 30cm and 10cm respectively. In addition, the width of the main channel between warehouses should not be less than 200 cm, and the width of the auxiliary channel should not be less than 100 cm.
(4) classified storage management
There should be warehouses suitable for classified management of drugs, which should be classified and stored according to the management requirements, uses and properties of drugs. Drugs that can be stored in the same warehouse, but should be stored in different locations are: drugs and non-drugs such as food and health care products, drugs for internal use and drugs for external use. Drugs that should be specially stocked and not mixed with other drugs in the same warehouse include: odorous drugs, Chinese herbal medicines, Chinese herbal pieces, specially managed drugs and dangerous goods.
(5) Temperature and humidity conditions
Drugs should be stored in corresponding warehouses according to the requirements of temperature and humidity, and all kinds of drug warehouses of drug trading enterprises should keep constant temperature. For each drug, it should be stored in cold storage (2- 10℃), cold storage (below 20℃) or normal temperature (0-30℃) according to the storage conditions indicated on the drug, and the relative humidity of each warehouse should be kept between 45% and 75%.
The temperature range required for cold storage, cold storage and normal temperature storage should be set scientifically and reasonably under the principle of ensuring the quality of drugs and meeting the storage conditions stipulated by drugs, that is, when the drugs in business are marked with what temperature and humidity to store, warehouses with corresponding temperature and humidity ranges should be set up. If the label is drugs stored at 15-25℃, a constant temperature warehouse at 15-25℃ shall be set up.
Drugs marked with two or more different storage conditions of temperature and humidity should generally be stored in warehouses with relatively low temperatures. For example, if the storage conditions of a drug label are: 3 years below 20℃, 20-30℃ 1 year, the drug should be stored in a cool warehouse.
(6) Storage of Chinese herbal medicines and Chinese herbal pieces
Corresponding storage warehouses should be set up according to the nature of Chinese herbal medicines and Chinese herbal pieces, and the temperature and humidity conditions should be controlled reasonably. Varieties that are easy to be moth-eaten, mildewed, greasy and discolored shall be provided with a sealed, dry, cool and clean warehouse; Varieties with small business volume, easy discoloration, volatilization and melting should be equipped with storage equipment such as refrigerators and freezers to avoid light and heat.
Requirements: (1) Basic requirements for personnel.
qualified
Person in charge of quality management organization: according to the size of the enterprise, there should be full-time personnel who meet the qualifications of the person in charge of quality of the enterprise, can adhere to principles and have practical experience in solving quality problems independently in the actual work process.
Personnel in charge of drug quality management, inspection, acceptance, maintenance and measurement: wholesale enterprises shall have no less than 4% of the total number of employees and at least 3 employees; Retail chain enterprises shall not be less than 2% of the total number of employees, and the minimum number shall not be less than 3.
health examination
Direct contact with drugs: physical examination at least once a year.
Quality management, drug acceptance, maintenance and storage: regular inspection.
Diseases that do not engage in direct contact with drugs: mental illness, infectious diseases and other diseases that may contaminate drugs.
Personnel training and education
Quality management and acceptance personnel: they should receive continuing education organized by provincial drug supervision departments every year.
Maintenance and metrology personnel: regularly receive continuing education organized by enterprises.
Training and education contents: 1, drug laws and regulations 2, professional technology, drug knowledge and professional ethics.
(2) Requirements for facilities and equipment
1, warehouse area (building area)
Small enterprises 500 m medium-sized enterprises 1000m large enterprises 1500 m.
2. Temperature and humidity conditions
There is a warehouse suitable for classified storage of drugs and meeting the requirements of drug storage: the temperature of cold storage is 2℃-10℃; Refrigeration temperature:
3, drug testing room
Area: large enterprises: 150 m medium enterprises: 100 m small enterprises: 50 m.
4, acceptance curing room
Area: large enterprises: 50 m medium-sized enterprises: 40 m small enterprises: 20m.
Equipment: Moisture-proof and dust-proof instruments:11000 balance, clarity detector, standard colorimetric solution, disintegrator, moisture analyzer of Chinese herbal medicine instrument, ultraviolet fluorescent lamp and microscope.