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GMP Information Handbook: Sales Management and Drug Management

2022-03-25

Original

Marya

 Quastions and Answers ...................................................................................................................................................................

 

 

1. What should be included in the sales records of finished products?

There should be sales records for each batch of finished products. The sales of each batch of products can be tracked according to the sales records, and all can be recovered in time if necessary. The sales records include: product name, dosage form, batch number, specification, quantity, recipient company and address, delivery date, serial number, inspection report number.

 

2. How long should sales records be kept?

Sales records should be kept for one year after the expiration date of the drug. For drugs with no specified expiration date, their sales records shall be kept for 3 years.

 

3. What should be included in the drug return record?

The drug return record includes: serial number, product name, batch number, specification, quantity, consigner and consignee address, reason for return, date of return and return, and handling opinions.

 

4. How to deal with returned drugs with quality-related reasons?

The quality-related returns and recalls due to external reasons, such as damaged packaging, shortage of quantity or overstocked sales, will be checked by the quality assurance department. If no internal quality change is confirmed, the returned drug will be reprocessed. The batch number of reprocessed products must include the reprocessing mark, and the quality inspection department must pass the inspection and sign the inspection report before it can be resold. Returned and recalled medicines which have internal quality changes should be destroyed under the supervision of the quality assurance department, and other relevant batches should be dealt with at the same time.

 

5. Can a salesperson sell other company's drugs?

A salesperson CANNOT sell other company’s drugs. According to Article 35 of Measures for the Supervision and Administration of Circulation of Pharmaceuticals issued by the State Food and Drug Administration, drug salespersons cannot sell drugs of other companies. Violations of the regulations shall be given a warning or/and imposed a fine of not more than 20,000 yuan. Therefore, salespersons can only sell their own company's products.

 

6. What are GSP, GLP, GCP, GAP?

GSP stands for Good Supply Practice, which are the standards that pharmaceutical companies must comply with;

GLP stands for Good Laboratory Practice, which are regulations on quality and integrity of non-clinical laboratory studies.

GCP stands for Good Clinical Practice;

GAP stands for Good Agricultural Practice for Chinese Crude Drugs.

 

7. What is an OTC drug?

OTC medicines are over-the-counter medicines, also known as popular medicines, which are medicines that can be purchased and used according to one’s own judgement, without a doctor's prescription.

 

8. What are the unique features of drug products?

Drugs products have the following unique features: complex variety, medical specificity, strict quality, production specifications, duality of use, scientific approval, professional inspection, timeliness of use, and invaluable benefits.

 

9. How many chapters and articles does The Drug Administration Law have? When did it become effective?

The Drug Administration Law was passed on September 20, 1984 by the Seventh Session of the Fifth National People's Congress. It consists of eleven chapters and sixty articles. It became effective on July 1, 1985; The tenth meeting revised it to ten chapters and one hundred and six articles, and the new law came into force on December 1, 2001.

 

10. What is the National Drug Standard?

The Pharmacopoeia of the People's Republic of China and drug standards promulgated by the drug regulatory department of the State Council are the national drug standards. Medicine must meet national standards.

 

11.What are the categories of new Chinese medicine? How is it divided?

In China, new traditional Chinese medicine is divided into five categories:

Category 1:

(1) Man-made products of Chinese herbal medicines.

(2) Newly discovered Chinese herbal medicine and their preparations.

(3) Active ingredients extracted from Chinese medicinal materials and their preparations.

Category 2:

⑴ Chinese medicine injection.

(2) New medicinal parts of Chinese medicinal materials and their preparations.

(3) Effective parts extracted from Chinese medicinal materials and natural medicines and their preparations.

⑷ Chinese herbal medicines are artificially prepared in animals and their preparations.

Category 3:

⑴ new traditional Chinese medicine preparations.

(2) Chinese and Western medicine compound preparations based on traditional Chinese medicine.

(3) The customary imported medicinal materials and their preparations that are introduced from abroad or introduced from domesticated animals.

Category 4:

(1) Drugs that change the dosage form or change the route of administration.

(2) Domestically introduced or wild animal and plant medicinal materials.

Category 5:

New medicine for treating diseases and syndromes.

 

12. What are the categories of new drugs (Western Drugs) in China? How is it divided?

5 categories

Category 1: Innovative drugs that have not been marketed at home or abroad. Refers to drugs containing new compounds with clear structures and pharmacological effects and with clinical value.

Category 2: Improved new drugs that have not been marketed at home or abroad. It refers to a drug whose structure, dosage form, prescription process, route of administration, indications, etc. are optimized on the basis of known active ingredients, and has obvious clinical advantages.

Category 3: The domestic applicant imitates the drugs marketed overseas but the original drugs that are not marketed in China. Such drugs should be of the same quality and efficacy as the original drug.

The original research drug refers to the first drug approved for marketing at home and abroad, and has complete and sufficient safety and efficacy data as the basis for marketing.

Category 4: The domestic applicant imitates the original drug that has been marketed in China. Such drugs should be of the same quality and efficacy as the original drug.

Category 5: Drugs marketed overseas apply for domestic marketing.

 

13. When producing a new drug, which department must approve it, and does the workshop that produces the dosage form have to be GMP certified?

When producing a new drug, it must be approved by the State Drug Administration and issued an approval number, and the workshop that produces the dosage form must pass GMP certification.

 

14. Can generic drugs be copied without GMP certification?

No. The State Drug Administration stipulates that only companies that have passed GMP certification can imitate drugs.

 

15. What are the requirements for generic drugs?

  • When imitating a drug, you must first inquire at the "Committee for Protected Varieties of Traditional Chinese Medicine", and the varieties that have not been protected by traditional Chinese medicines can be copied;
  • Fill in the application for imitation report and get approval from the Provincial and State Drug Administration;
  • Strict trial production according to the technology of imitation varieties;
  • Carry out standard improvement work on the basis of the original standard (such as increasing content determination, etc.);
  • Carry out stability test;

 

16. What is the period of protection for new drugs?

A new drug is protected after it is approved by the State Drug Administration and issued a new drug certificate. The protection period of various new drugs is: 12 years for the first category of new drugs; 8 years for the second and third categories of new drugs; 6 years for the fourth and fifth categories of new drugs.

 

17. Is the protection of traditional Chinese medicine varieties the same as the protection of new drugs?

The two are not the same, but the effect is the same. New drug protection refers to the protection period given by the state when a new drug developed is approved. The purpose is to encourage innovative new drugs, protect the enthusiasm of scientific research and production units for research, development and production of new drugs, and avoid repeated research and production. The protection of traditional Chinese medicine varieties is the hierarchical protection of traditional Chinese medicine varieties with stable quality and definite curative effect by the drug regulatory department of the State Council in order to improve the quality of drugs, protect the legitimate rights and interests of traditional Chinese medicine manufacturers, and promote the development of traditional Chinese medicine.

 

18. Grading standard of powder fineness

The coarsest powder refers to the powder that can all pass through the No. 1 sieve, but is mixed with no more than 20% of the powder that can pass the No. 3 sieve;

Coarse powder refers to the powder that can pass through the No. 2 sieve, but is mixed with no more than 40% of the powder that can pass through the No. 4 sieve;

Medium powder refers to the powder that can all pass through the No. 4 sieve, but mixed with no more than 60% of the powder that can pass through the No. 5 sieve;

Fine powder refers to the powder that can pass through the No. 5 sieve and contains no less than 95% of the powder that can pass through the No. 6 sieve;

The finest powder refers to the powder that can pass through the No. 6 sieve and contains no less than 95% of the powder that can pass through the No. 7 sieve;

Very fine powder refers to the powder that can pass through the No. 8 sieve and contains no less than 95% of the powder that can pass through the No. 9 sieve;

 

19. Conversion of sieves and milling fines used in the Chinese Pharmacopoeia

Sieve No.

Mesh Opening Size（Average）

Mesh Opening Number

Sieve #1

2000μm±70μm

10

Sieve #2

850μm±29μm

24

Sieve #3

355μm±13μm

50

Sieve #4

250μm±9.9μm

65

Sieve #5

180μm±7.6μm

80

Sieve #6

150μm±6.6μm

100

Sieve #7

125μm±5.8μm

120

Sieve #8

90μm±4.6μm

150

Sieve #9

75μm±4.1μm

200

 

20. Legal measurement unit name and English symbol

Physical Quantity

Measurement Unit and Symbol

Length

meter(m), decimeter（dm）, centimeter（cm）, millimeter（mm）、micrometer（μm）, nanometer（nm）

Volume

liter（L）, milliliter（ml）, microliter（μl）

Mass

kilogram（kg）,gram（g）, milligram（mg）, microgram（μg）

Pressure

Megapascal（Mpa）, kilopascal（Kpa）, pascal（pa）

Dynamic Viscosity

Pascal second（pa.s）

Kinematic Viscosity

square millimeters per second（mm²/s）

Wavenumber

reciprocal centimeter（cm-1）

Density

kilograms per cubic meter（kg/m³）、grams per cubic centimeter（g/m³）

Radioactivity

gigabeq（GBq）, megabeq（MBq）, Kilobeq（KBq）, beq（Bq）

 

21. Different water temperatures in degrees Celsius (°C)

Unless otherwise specified, the temperature of the water bath refers to 98 ~ 100 ℃

Hot water refers to 70～80℃

Lukewarm or lukewarm water refers to 40～50℃

Room temperature refers to 10～30℃

Cold water refers to 2～10℃

Ice bath refers to below 2°C

Let cool means let cool to room temperature

 

22. National basic medical insurance drugs:

This variety should be clinically necessary, safe, effective, reasonably priced, easy to use, and the market can guarantee the supply of drugs, and designated by the relevant state departments as drugs for reimbursement by employees participating in medical insurance.

 

23. Counterfeit medicine: A counterfeit medicine is one of the following:

(1) The ingredients contained in the drug do not conform to the ingredients specified in the national drug standards;

(2) Passing off non-drugs as medicines or using other medicines as such medicines.

Drugs that fall under any of the following circumstances shall be treated as counterfeit drugs:

(1) The use of which is prohibited by the provisions of the drug regulatory department of the State Council;

(2) Manufacturing or importing without approval as required under this Law, or selling without inspection as required under this Law;

(3) spoiled;

(4) Contaminated;

(5) Production of APIs that must obtain an approval number in accordance with this law but have not obtained an approval number;

⑹ The indicated indications or functional indications exceed the specified range. (Excerpted from the Medicines Act)

 

24. Inferior drugs: If the content of drug ingredients does not meet the national drug standards, it is an inferior drug.

Drugs that fall under any of the following circumstances shall be treated as inferior drugs:

(1) The validity period is not marked or the validity period is changed;

(2) Not indicating or changing the production batch number;

(3) Exceed the validity period;

(4) Unapproved packaging materials and containers that come into direct contact with drugs;

⑸ Adding colorants, preservatives, spices, flavoring agents and auxiliary materials without authorization;

⑹ Others that do not meet the requirements of drug standards. (Excerpted from the Medicines Act)

 

25. Non-prescription drugs:

Also known as Over The Counter, or OTC for short. It refers to the safe and effective drugs that consumers can judge and use according to the instructions of the drug without the need of a doctor's prescription. That is, consumers can buy medicines directly from pharmacies or drugstore counters or even supermarkets without the guidance of doctors or other medical personnel based on their own medical knowledge.

OTC drugs are divided into Type A OTC drugs and Type B OTC drugs.

For non-prescription drugs, the logo pattern is divided into red and green. The red special logo is used for Class A non-prescription drugs, and the green special logo is used for Type B non-prescription drugs. Among them, Type B over-the-counter drugs can be retailed in supermarkets.

 

26. Prescription drugs:

Prescription drugs are medications that require a doctor's prescription can only be purchased in pharmacies or drugstores with a doctor's prescription and can be used under the guidance of doctors or other medical personnel.

 

27. Chinese patent medicine:

Chinese patent medicine is pills or other forms of Traditional Chinese medicine made from Chinese herbal medicine.