Discussion on the marking method of the production

2022-09-28
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Discussion on the marking method of the production date and expiry date of drug packaging

Article 54 of the drug administration law of the people's Republic of China stipulates: "The drug packaging must be printed or pasted with labels and instructions in accordance with the regulations. The general name, ingredients, specifications, manufacturer, approval number, product batch number, production date, expiry date, indications or functions, usage, dosage, contraindications, adverse reactions and precautions of the drug must be indicated on the labels or instructions.". The drug manufacturers are different when marking the production date, batch number and expiration date of drugs. For example, for the labeling of the validity period of drugs, the same kind of drugs implement the national unified standards, and the validity period is the same, but the manufacturers are different, and the labeling of the validity period is also different. For example, the production date of a drug is May 10, 2003, and the validity period is one year. Some manufacturers label it as "validity period: April 2004", while some manufacturers label it as "validity period: May 2004", Others are marked as "valid until: May 9th, 2004"; Another example is the marking of production date. Some manufacturers mark the date when the drug batch number is formed, and some manufacturers mark the date when the drug starts feeding. Due to the inconsistency of the production date and validity period of drugs marked by various drug manufacturers, it is inconvenient for consumers and drug trading enterprises to identify the production date of drugs, especially the validity period of drugs, when purchasing and accepting drugs. It is suggested that the drug supervision department should have a unified regulation on the marking of the drug production date and expiry date of each drug production enterprise. Perhaps it is more convenient for consumers to identify drugs when purchasing drugs. It is also more convenient for drug dealers to check and accept purchased drugs, and it also provides a unified standard for the supervision and management of the national drug supervision department. According to the relevant national regulations and the labeling of drug manufacturers, it is suggested that the production date and expiration date on the drug package should be marked in the following way

I. mark the drug production date

1. Mark the drug production date

it is recommended that the production date of the drug be marked as the date when the drug preparation starts feeding, because the date when the drug preparation starts feeding is the beginning of drug production. According to the provisions of the 98 revision of the "good manufacturing practice for drugs", the production time of the general drug production batch number is not the time when the drug begins to be fed, but in the intermediate stage of the drug production process. For example, in the working process, the volume must be sealed. The homogeneous products produced by using the same mixing equipment for one mixing volume of non sterile drug solid and semi-solid preparations before forming or sub packaging are a batch; Liquid preparations are a batch of homogeneous products produced by the last mixed liquid before filling (sealing); The homogeneous products produced by using the same mixing equipment at one time before forming or sub packaging of solid preparations of traditional Chinese medicine are a batch. The production time of the production batch number of some drugs is also the time when the drugs are put into production. For example, the division of batch numbers of large and small volume injections. Although some drug preparation production batch numbers are produced in the middle stage of the drug production process, generally the date of drug batch number formation is within the same day as the date of drug feeding, but some drug batch number formation date and feeding date are not the same day, feeding is in front, and the batch number is determined to be in the back. Some enterprises mark the production date of drugs as the formation date of drug batch number or the packaging date of drugs. If the formation date of drug batch number is the same as the feeding date, the production date is the formation date of batch number. If the batch number is not the same as the feeding date, it is obviously inappropriate to mark the production date as the formation date of batch number; It is more inappropriate to introduce the new material of production date, which is mainly developed by expert teams from the United States and South Korea, and mark it as the packaging date, because the packaging date is the final stage of the whole drug production process. Generally, there is a certain time period from the feeding of drugs to the warehousing of finished products. The time from the feeding of drugs to the packaging of drugs can be as long as ten days, or even half a month, or more, so it is more appropriate to mark the drug production date as the drug feeding date

II. Marking of the period of validity of drugs

Guo Yao Jian ban [2001] No. 391 "notice on strengthening the management of the period of validity of drugs and making preparations for the implementation of the newly revised Drug Administration Law of the people's Republic of China" stipulates that all drugs produced and marketed after December 1, 2001 must be marked with the period of validity, and drugs without the period of validity shall not be produced and sold; At the same time, it is required that each smallest packaging unit of the drug should indicate the expiration date of the drug before it can be sold out of the factory. It also states that "the method of indicating the period of validity can be stamped or stamped on the package, label and instructions" the period of validity expires ×× year ×× Month. There are different ways to express the validity period of drugs, and the marked dates are also different. For example, the production date of drugs is February 3, 2003, and the validity period is 3 years, then the validity period should be marked as: "validity period: January 2006. At present, the labeling method used by all drug manufacturers in China is" validity period to ". Its calculation method is: add the validity time to the month and year marked on the production date, The year and month of "validity period to" should be marked by subtracting one month. For example, the drug production date is 040501, and the validity period is one year. Its validity period should be marked as "validity period to: April 2005", which represents the drug produced in May 2004, and the validity period is one year. The drug is valid until 24:00 on April 30, 2005. It is obviously inappropriate for some manufacturers to mark "valid until May 2004". Drugs are special commodities, and patients can only take them within their validity period, not after they exceed the validity period. In order to make it convenient for patients to ensure that the drugs are taken within the validity period, it is recommended to mark the date of validity of the drugs. For example, if the production date of the drugs is October 20, 2004 and the validity period is two years, the validity period is marked as "validity period to: October 19, 2006". For ordinary patients, marking the validity period to year, month and day is easier to understand and judge the specific expiration date of the drugs than only marking to year and month

in order to make drugs have a unified identification in the field of production and circulation, and bring convenience to consumers' identification of drug production date and expiration date, as well as the unified supervision and management of drug supervision and administration departments, it is suggested that drug supervision and administration departments should have a unified requirement on the marking of drug production date and expiration date on statically calculated product packages for the purpose of tightening production capacity of drugs

(1 Shijiazhuang Kedi Pharmaceutical Co., Ltd. 2 Shenwei Pharmaceutical Co., Ltd. Qi Wenbo 1 Li Yingli 2

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