112 Basic GMP Knowledge Q&As （Q86-112）

Till today, we have shared 112 Basic GMP Knowledge Q&As, Please subscribe to our GMP EXPLAINED

86. What items are included in the finished product sales records?

Answer: Each batch of finished products should have sales records. Based on the sales records, the sales situation of each batch of products can be traced, and if necessary, all can be promptly recalled. The contents of the sales records include: product name, dosage form, batch number, specifications, quantity, recipient unit and address, shipping date, serial number, and inspection report number.

87. How long should sales records be kept?

Answer: Sales records should be kept for one year after the expiration date of the drug. For drugs without a specified expiration date, sales records should be kept for 3 years.

88. What does the drug return and recovery record contain?

Answer: The return and recovery record includes: serial number, product name, batch number, specifications, quantity, the unit of return and recovery and address, the reason for return and recovery, the date of return and recovery, and processing opinions.

89. How are returns due to quality reasons handled?

Answer: For drugs returned and recovered due to external quality reasons, such as damaged packaging, shortage of quantity, or sales backlog, the quality assurance department will inspect them and, upon confirming no internal quality change, decide on rework processing. The batch number of reworked products must be marked with a rework identifier, and after passing the inspection by the quality inspection department and receiving the inspection report, they can be resold. Drugs returned and recovered due to internal quality changes should be destroyed under the supervision of the quality assurance department, and if other batch numbers are involved, they should be dealt with simultaneously.

90. Can sales personnel sell products from other companies?

Answer: No. According to Article 35 of the "Drug Distribution Supervision and Administration Measures" issued by the State Drug Administration, drug sales personnel cannot engage in drug purchasing and selling activities for other companies on a part-time basis. Violators will be warned or fined up to twenty thousand yuan. Therefore, sales personnel can only sell products from their own company.

91. What are GSP, GLP, GCP, and GAP?

Answer: GSP is the abbreviation for "Good Supply Practice for Pharmaceutical Products," which is the standard that pharmaceutical business enterprises should comply with; GLP stands for "Good Laboratory Practice for Non-Clinical Drug Studies"; GCP stands for "Good Clinical Practice for Drug Clinical Trials"; GAP stands for "Good Agricultural Practice for Chinese Medicinal Materials."

92. What are OTC drugs?

Answer: OTC drugs, or Over-The-Counter drugs, are also known as non-prescription drugs. They are drugs that can be purchased and used by individuals without a doctor's prescription based on self-judgment.

93. What are the special characteristics of drugs?

Answer: Drugs have the following special characteristics: complexity of types, medical professionalism, strictness in quality, specification in production, duality in use, scientific nature of approval, professionalism in inspection, timeliness in use, and invaluable efficacy.

94. How many chapters and articles does the "Drug Administration Law" have, and when was it implemented?

Answer: The "Drug Administration Law" was passed on September 20, 1984, by the Seventh Session of the Fifth National People's Congress, consisting of eleven chapters and sixty articles, and was implemented on July 1, 1985. It was revised on February 28, 2001, by the Twentieth Session of the Ninth National People's Congress, changing to ten chapters and one hundred and six articles. The new law has been in effect since December 1, 2001.

95. What is the national drug standard?

Answer: The "Pharmacopoeia of the People's Republic of China" and drug standards issued by the drug supervision and administration department of the State Council are the national drug standards. Drugs must comply with national standards.

96. How are new Chinese medicines classified in China? How are they categorized? Answer:

New Chinese medicines in China are divided into five categories: First category:

(1) Artificially made products of Chinese medicinal materials.

(2) Newly discovered Chinese medicinal materials and their preparations. (3) Effective components extracted from Chinese medicinal materials and their preparations. Second category: (1) Chinese medicine injections. (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.

(4) Products obtained through artificial methods in animals and their preparations. Third category: (1) New Chinese medicine preparations. (2) Compound preparations of Chinese and Western medicine mainly consisting of Chinese medicine. (3) Habitually imported medicinal materials and their preparations introduced or cultivated from abroad. Fourth category: (1) Drugs with changed dosage forms or administration routes. (2) Medicinal materials of plants and animals introduced or domesticated from different regions within the country. Fifth category: Drugs with added new indications.

97. How are new drugs (Western medicines) classified in China? How are they divided?

Answer: There are 5 categories:

Category 1: Innovative drugs not marketed domestically or internationally. This refers to drugs containing new, structurally defined compounds with pharmacological effects and clinical value.

Category 2: Improved new drugs not marketed domestically or internationally. These are drugs optimized based on known active ingredients in terms of structure, dosage form, prescription technology, administration route, indications, etc., and have significant clinical advantages.

Category 3: Drugs for which domestic applicants replicate overseas marketed but domestically unmarketed original research drugs. These drugs should be consistent in quality and efficacy with the original research drugs. Original research drugs refer to the first drugs approved for marketing domestically or internationally, with complete and sufficient safety and efficacy data as the basis for marketing approval.

Category 4: Drugs for which domestic applicants replicate domestically marketed original research drugs. These drugs should be consistent in quality and efficacy with the original research drugs.

Category 5: Drugs marketed abroad applying for domestic marketing.

98. When producing new drugs, which department must approve, and must the workshop producing the dosage form be GMP certified?

Answer: When producing new drugs, approval must be obtained from the National Medical Products Administration and an approval number issued. Additionally, the workshop producing the dosage form must be GMP-certified.

99. Can drugs be replicated without GMP certification?

Answer: No. According to regulations from the National Medical Products Administration, only enterprises that have passed GMP certification are allowed to replicate drugs.

100. What are the requirements for replicating drugs?

Answer:

(1) When replicating drugs, it is necessary to first inquire with the "Traditional Chinese Medicine Protected Varieties Committee," and only those varieties not protected by traditional Chinese medicine can be replicated;

(2) Submit an application report for the intended replication for approval by the provincial and national medical products administrations;

(3) Strictly trial-produce according to the technology of the replicated variety;

(4) Improve standards based on the original standards (e.g., adding content determination);

(5) Conduct stability tests;

(6) After inspection and review by the provincial drug inspection institute, submit for approval by the National Medical Products Administration.

101. How is the protection period for new drugs defined?

Answer: New drugs receive protection once approved and issued a new drug certificate by the National Medical Products Administration. The protection periods for different types of new drugs are as follows:

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.

During the protection period, no unit may replicate them.

102. Is the protection for traditional Chinese medicine varieties the same as for new drugs?

Answer: They are not the same, but the effect is the same. New drug protection refers to the protection period given by the state at the time of approval of newly developed drugs. The purpose is to encourage the innovation of new drugs and protect the enthusiasm of research, development, and production units for new drugs, avoiding repeated research and production. Traditional Chinese medicine variety protection, on the other hand, is the graded protection implemented by the drug supervision and administration department of the State Council to improve the quality of drugs, protect the legitimate rights and interests of traditional Chinese medicine production enterprises, and promote the development of the traditional Chinese medicine industry.

103. The grading standard for drug powder fineness

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

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

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

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

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

Extra fine powder refers to powder that can completely pass through a No. 8 sieve, and contains no less than 95% of powder that can pass through a No. 9 sieve.

104. Conversion of the sieves used in the Chinese Pharmacopoeia to powder

particle size Sieve number Sieve hole diameter (average value)

Mesh number No. 1 sieve 2000μm±70μm 10 mesh

No. 2 sieve 850μm±29μm 24 mesh

No. 3 sieve 355μm±13μm 50 mesh

No. 4 sieve 250μm±9.9μm 65 mesh

No. 5 sieve 180μm±7.6μm 80 mesh

No. 6 sieve 150μm±6.6μm 100 mesh

No. 7 sieve 125μm±5.8μm 120 mesh

No. 8 sieve 90μm±4.6μm 150 mesh

No. 9 sieve 75μm±4.1μm 200 mesh

105. Names and English symbols of legal measurement units Length meter (m) decimeter (dm) centimeter (cm)

Millimeter (mm) micrometer (μm) nanometer (nm)

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

Mass (weight) kilogram (kg) gram (g) milligram (mg)

Microgram (μg) Pressure megapascal (Mpa) kilopascal (Kpa) pascal (pa) Dynamic viscosity pascal-second (pa.s)

Kinematic viscosity square millimeter per second (mm2/s)

Wavenumber reciprocal centimeter (cm-1)

Density kilogram per cubic meter (kg/m3)

Gram per cubic centimeter (g/cm3)

Radioactivity becquerel (Bq) gigabecquerel (GBq) megabecquerel (MBq) Kilobecquerel (KBq)

106. Celsius temperature representations for different water temperatures

Water bath temperature, unless otherwise specified, refers to 98–100°C

Hot water refers to 70–80°C

Lukewarm or warm water refers to 40–50°C

Room temperature refers to 10–30°C

Cold water refers to 2–10°C Ice bath refers to below 2°C

Cooling refers to cooling to room temperature

107. National basic medical insurance drugs:

These drugs should be clinically necessary, safe and effective, reasonably priced, convenient to use, and their market supply should be guaranteed. They are designated by relevant national departments as drugs for which employees participating in medical insurance can be reimbursed.

108. Counterfeit drugs: Drugs are considered counterfeit if they fall under one of the following conditions:

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

(2) Non-drug substances are passed off as drugs, or one type of drug is passed off as another type. Drugs are considered counterfeit under one of the following conditions: (1) Use of drugs prohibited by the drug supervision and administration department of the State Council; (2) Produced, imported, or sold without approval or inspection required by this law;

(3) Deteriorated;

(4) Contaminated;

(5) Produced using active pharmaceutical ingredients without obtaining an approval number required by this law;

(6) The indicated uses or functions exceed the specified range. (Excerpted from the Drug Law)

109. Substandard drugs: Drugs are considered substandard if the content of their components does not meet the national drug standards. Drugs are considered substandard under one of the following conditions: (1) Not indicating the expiration date or altering the expiration date;

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

(3) Expired;

(4) Direct contact with drug packaging materials and containers not approved;

(5) Unauthorized addition of colorants, preservatives, flavorings, flavor correctors, and excipients;

(6) Other non-compliances with drug standards stipulated. (Excerpted from the Drug Law)

110. Over-the-counter drugs: Also known as OTC (OverTheCounter) drugs. These are safe and effective drugs that do not require a physician's prescription and can be judged and used by consumers based on the drug's instructions. That is, consumers can purchase these drugs directly from pharmacies or drugstore counters, or even supermarkets, based on their own medical knowledge without the guidance of a physician or other medical personnel. OTC drugs are divided into Class A and Class B non-prescription drugs. Special marks for OTC drugs are divided into red and green. The red special mark is used for Class A non-prescription drugs, and the green special mark is used for Class B non-prescription drugs, which can be retailed in supermarkets.

111. Prescription drugs: These are drugs that can only be purchased from pharmacies or drugstores with a doctor's prescription and should be used under the guidance of a doctor or other medical personnel.

112. Chinese patent medicines: These are traditional Chinese medicine preparations made from Chinese herbal medicines.

?

#GMPInsights #QualityAssurance #PharmaGMP #GMPCompliance #DrugSafety #GMPStandards hashtag#Pharmaceuticals #QualityControl #GMPTraining #GMPExplained #HyperchemGMP