Training questions of "Good Quality Management Standard for Pharmaceutical Trading"
Position: Name: Performance:
I. Fill in the blanks (***40 points) (2 points for each question)
1, enterprises should set up a special quality management organization, its members include.
2. Enterprises should engage in pharmaceutical business activities in accordance with the legally approved business methods.
3, enterprise quality management institutions should be responsible for drug quality and drug quality accidents or quality complaints, and report.
4. Enterprises should conduct internal audit on the implementation of ""on a regular basis.
5. The temperature of warehouses and normal-temperature warehouses that meet the requirements of classified drug storage is, the refrigeration temperature is not higher than, the refrigeration temperature is, and the relative humidity of each warehouse should be kept between.
6, narcotic drugs, psychotropic drugs, medical toxic drugs, should implement the system.
7, unqualified drug processing should be carried out regularly.
8. Drug acceptance records shall be kept until the drug is valid for more than years, and shall not be less than years.
9, unqualified drugs should be stored in.
10, the drugs purchased by enterprises should have legal _ _ _ _ _ _ _ _ and _ _ _ _ _, except as stipulated by the state.
Second, multiple-choice questions (5 points for each question, *** 15 points)
1. Enterprises shall establish drug sales records in accordance with regulations to record drugs: ()
A product name, manufacturer and buyer of dosage form B, sales quantity C specification, expiration date, sales date, etc.
2. The system formulated by the enterprise shall include: ()
A quality policy and target management B quality system audit quality responsibility C quality veto regulation D quality information management first business and first variety audit E quality acceptance management warehousing, maintenance and outbound review management F related records and vouchers, special drugs and expired drugs unqualified drugs and returned drugs management G quality accidents, quality inquiry and quality complaints management H regulations on adverse drug reaction report, hygiene and personnel health status management I quality education, training and assessment, etc.
3, drug delivery review, should be based on the factory certificate for physical quality inspection and quantity, project check. Re-inspection records for the convenience of quality tracking shall include: ()
A buyer, product name, dosage form, specification B, batch number, expiration date, manufacturer and quantity.
C sales date, quality status and reviewer d have the name and approval number.
Three. True or false questions (5 points for each question, * * * 25 points)
1, personnel engaged in quality management in enterprises can work part-time ()
2, the whole package acceptance should have the product certificate ()
3, acceptance must be carried out in the prescribed place and completed within the prescribed time limit ().
4. Return records need to be kept for one year ()
5, enterprise sales staff can appropriately exaggerate () when introducing drugs.
Four. Question and answer (each question 10, ***20)
1. What problems should enterprises find when they leave the warehouse and report them to relevant departments for handling?
2. How many areas and colors should the warehouse be divided into? What is the color code corresponding to each area?
answer
I. 1, Quality Management Group and Quality Acceptance Group
2. Mode of operation and business scope
3. Inquiry, investigation and handling
4, "drug quality management standard"
5、0-30℃、20℃、45%-75%
6. Double acceptance
7. Summary and analysis
8、 1,3
9. Unqualified areas
10, approval number and production batch number
Second, 1. ABC 2。 Select all three. American Broadcasting Company Inc (ABC)
Three. 1.× 2.√ 3.√ 4.× 5.×
Fourth, 1.
(1) Abnormal sound and liquid leakage in drug packaging.
(2) The outer package is damaged, the seal is not firm, the gasket is false, and the seal is seriously damaged.
(3) The packaging label is fuzzy or falls off.
(4) The drug has expired.
2 drug storage warehouses should be partitioned, and the reservoir area should be managed by color codes. The warehouse should be divided into five areas: qualified area, unqualified area, pending inspection area, return area and delivery area. The color code of each reservoir area must correspond correctly to avoid misuse and confusion. The return area to be inspected is yellow, the qualified area and delivery area are green, and the unqualified area is red.