A pharmaceutical company was fined 3 million in the batch number change!

Credit China recently disclosed an administrative penalty case.
Gansu Pu'ankang Pharmaceutical Co.
, Ltd.
changed the batch number of three (42 kg) poppy shell products from C12101004 to C12101002 and sold them, in order to conceal the change of batch number and fabricate production records
.

In the end, he was punished:

1.
Order to suspend production and business for rectification;

2.
Confiscated 3 pieces (42 kilograms) of inferior drug poppy shells produced and sold illegally, and confiscated 2608.
2 yuan of illegal income;

3.
A fine of 3 million yuan was also imposed
.

The above fines and confiscated amounts to 3002608.
2 yuan

Basis for punishment:

According to the provisions of Article 117, Paragraph 1, Article 124, Paragraph (6), and Article 126 of the "Drug Administration Law of the People's Republic of China" (revised in 2019)
.

▍Illegal facts

1.
Gansu Pu'ankang Pharmaceutical Co.
, Ltd.
changed the batch number of three (42 kg) poppy shell products from C12101004 to C12101002 and sold them.
The three products whose batch numbers were changed belong to the "Pharmaceutical Administration Law of the People's Republic of China" (revised in 2019) Article 98 The conditions specified in item (4) of the third paragraph of Article 98 shall be inferior drugs
.

2.
In order to cover up the behavior of changing the batch number, Gansu Pu'ankang Pharmaceutical Co.
, Ltd.
recorded the batch number as C12101004 as the actual production quantity and the warehousing quantity as 1779 when filling in the finished product packaging record and the finished product storage record in the batch production record.
, And adopted the method of increasing the "production process loss" to calculate the material balance.
The above-mentioned act of fabricating production records violates the provisions of Article 44 Paragraph 1 of the "Pharmaceutical Administration Law of the People's Republic of China" (revised in 2019)
.

▍On-site inspection also found 7 defects

1.
The 4 batches of poppy shell products produced by Gansu Pu'ankang Pharmaceutical Co.
, Ltd.
in January 2021 have a morphine content of 0.
40%, which is the upper limit of the standard, marginal data, and no retest verification records;

2.
The poppy shell (YL20201218-12) inspection record and inspection report did not show the material code of the raw material, and it did not comply with Article 223 (2) Item of the "Pharmaceutical Production Quality Management Regulations (Revised in 2010)" Requirements for item 4, item (3), item (6), item 1;

3.
The 0.
01mol/L sodium hydroxide titration solution used for the determination of sulfur dioxide residues is stored in the laboratory cabinet.
There is no special constant temperature and humidity storage area and the re-standard record is prepared before use.
It does not meet the "Pharmaceutical Production Quality Management Regulations (Revised in 2010) 》The requirements of items (3) and (4) of Article 226;

4.
The management of anesthetic standard materials lacks clear and accurate dynamic management accounts.
The standard of preparation of reference substance solution has a validity period of 3 months, and there is no stability test record.
Article 7 (1) and (3) requirements;

5.
Failure to investigate and evaluate the errors in the wholesale of poppy shell C12101002, without relevant records, and fail to meet the requirements of Article 249 of the "Good Manufacturing Practice for Drugs (Revised in 2010)";

6.
The finished product entry and exit records are inconsistent with the actual situation, and do not meet the requirements of Article 295 of the "Pharmaceutical Production Quality Management Regulations (Revised in 2010)";

7.
The raw material poppy husk (YL20191117-01) has a morphine content of 0.
92%.
The poppy husk process specification does not specify the feeding and mixing ratio.
The C12012063 batch of poppy husk production ingredients audit form NO: 202012063 has no regulations on the mixing ratio of ingredients and does not comply with the "Drug Production Quality Management" Standardize (Revised in 2010)" Appendix "Chinese Medicine Decoction Pieces" Article 43 (2) and (4) requirements
.

The above-mentioned non-compliance with the "Good Manufacturing Practice for Drugs" violates the provisions of Article 43, Paragraph 1 of the "Drug Administration Law of the People's Republic of China" (revised in 2019)
.

Used to produce honey poppy shells without a license

The editor of Dandelion found that in 2017, Gansu Pu'ankang Pharmaceutical Co.
, Ltd.
was fined more than 10,000 yuan for producing honey poppy shells without obtaining a license
.

Without approval and without obtaining the "Drug Production License", the parties produced the Chinese medicine decoction pieces honey poppy with batch numbers C21703001, C21703002 and C21703003 on March 9, 2017, March 10, and March 11, respectively.
The shell is 140kg each, and the three batches total 420kg
.

In accordance with the provisions of Article 72 of the "Drug Administration Law of the People's Republic of China" and Article 27, paragraph 1 (4) of the "Administrative Punishment Law of the People's Republic of China," the following administrative penalties are imposed on the parties: 1.
Confiscation of illegal production The Chinese medicine decoction pieces honey poppy shell 420kg; 2.
A fine of twice the value of the illegally produced medicines was imposed, namely: 21420 yuan × 2=42,840 yuan (four million yuan)
.

1.
Confiscation of illegal income of 768 yuan; 2.
A fine of 10,000 yuan
.

Was stopped by the Drug Administration in February this year

The editor of Dandelion found through inquiry that Gansu Pu'ankang Pharmaceutical Co.

In the drug supervision and inspection organized by our bureau, it was found that the production of Chinese herbal medicine decoction pieces by Gansu Pu'ankang Pharmaceutical Co.

In accordance with the provisions of Article 99, Paragraph 3 of the "Pharmaceutical Administration Law of the People's Republic of China", our bureau has decided to suspend the production and sales of Chinese herbal decoction pieces of Gansu Pu'ankang Pharmaceutical Co.