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The production batch number is in industrial production. Although the raw materials and processes are the same, the quality and performance of the products produced by each batch of materials are still different. To
the responsibility of tracking this batch of products after the fact to avoid confusion, so each batch of products has a corresponding batch number. It is a set of numbers or letters plus numbers used to identify 'batch'
words. It is generally composed of two digits of the year, month, and day of the production time.
Definition and function of drug batch number. Article 76 of the 'Pharmaceutical Production Quality Management Regulations' promulgated by the Ministry of Health in 1992 stipulates the meaning of the term 'batch number': a term used to identify 'batch' Group numbers or
letters plus numbers. It can be used to trace and review the production history of the batch of drugs. It can be considered that this
is an interpretation of the lot number definition with legal significance.
In the production process, the drug batch number is mainly used for identification. It is produced at the stage of pharmaceutical production planning
, and corresponding content can be added with the advancement of the production process, and at the same time a corresponding
Production records. According to the production batch number and corresponding production records, the source of the raw materials of the batch of products and the history of the drug formation process can be traced; after the drug is formed into a finished product, the drug can be traced based on the sales record. The market destination of the drug; the quality of the drug after it enters the market; the batch of drugs can be controlled or recycled when needed. For drug supervisors
, the drug quality supervision and drug control can be carried out based on the random inspection of the batch of drugs and the conditions in use. In the use of drugs, the batch number of the drug is also involved.
Regarding the current compilation method of drug batch numbers, there are roughly two types in China. According to the relevant regulations of the Ministry of Health, the batch number is composed of day number and semicolon. The day number is a set of tables
The 6-digit number showing the date of production, and the semicolon is connected with the day number by a dash. The method of preparation is determined by the production unit according to the production date. The variety, craftsmanship, etc. are determined by oneself
〔1]. For example, batch number 980113-12, where 980113 is the date number, which means that the production date of the batch of drugs is January 13, 1998, and 12 is a semicolon, which means only
Producers know.
Article 4.2.3.2 of the 'Guidelines for the Implementation of Drug Manufacturing Quality Management Practices' stipulates the batch number preparation method, including normal batch numbers, reworked batch numbers, and mixed batch numbers.
〔2]. The normal batch number composition form is: year + month + serial number. For example, the batch number 980113, where 9801 indicates that the production time is January 1998, 13 is the serial number, the table
indicates that the batch is the 13th batch of production in January 1998.
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