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    Home > Medical News > Latest Medical News > How can the meaning of in-drug labeling just be compliance?

    How can the meaning of in-drug labeling just be compliance?

    • Last Update: 2021-01-31
    • Source: Internet
    • Author: User
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    According to a group of friends of a drug company's predecessors, problems were found while cleaning up their homes to store drugs.
    some of the drug minimum packaging does not have an expiration date logo, keep dare not use, throw away for fear of waste.
    , of course, first of all, is this in line with existing regulations? In the Regulations on the Administration of Drug Instructions and Labels (Regulation No. 24), "the labels in medicines shall contain the generic name of the drug, the applicable disease or functional treatment, specifications, usage, date of production, product lot number, expiration date, production enterprise, etc."
    if the inner packaging itself is very small, can not write so much content how to do? "If the packaging size is too small to be fully marked with the above-mentioned contents, at least the generic name, specifications, product lot number, expiration date and so on shall be marked."
    is it from here, people this kind of sealed bag packaging marked with validity period and other content in line with regulatory requirements?Wrong! There's a hidden point here, and that's the definition of "inner label."
    is an internal label? "In-drug labels are labels that come into direct contact with the packaging of a drug.
    " means that unless you have no other packaging in your sealed bag, it's just pharmaceutical particles or preparations.
    the label of this sealed bag, it cannot be called an internal label.
    the situation is that it is small white bottles, not sealed bags, that come into direct contact with the drugs.
    personally, it may have violated Order 24.
    this affect user usage? Probably, after all, as a result of removing the sealed bag, there is no information.
    risk eating it at an expiration date or you have to risk it being thrown away at the risk of waste.
    there is no risk to the production company? Of course! It is confusing not to have relevant information on the inner packaging.
    we assume a scenario in which a seller receives a complaint that the drug's lid on a batch number has changed.
    company's quality department hastened to take out to leave a kind of open look, found that the true nature is wrong.
    this must be investigated because it is not the same thing to be identified.
    most important thing is to see if there is any problem with the other adjacent batches first, so suddenly took four or five lot numbers on the table.
    opened one by one, found that there are two batches also belong to the character does not match.
    this time the problem came, a few people you take me to see, the sealing bag and bottle correspondence confused.
    't be sure which lot numbers have a problem.
    you do? Of course, as a business can argue that "we have strict control means, open the sealing bag, immediately mark the bottle, to ensure a one-to-one correspondence."
    then, you know that there is no such information in multiple batches of the site, need to be manually filled to avoid confusion, why not directly on the label design? What can be done with design, why risk confusion to reduce it with increased manual operation? Clearly this can avoid confusion, why do you have to reduce the probability of confusion occurring? Is it so hard to print the production date and expiration date on the internal label? The details, perhaps only the enterprise itself clear.
    if the inner packaging has a lot number and "three years shelf life" of the statement, is it perfect? No, it can even be said that there is a huge difference between the identification of the lot number and the date of production.
    image below is a package of drugs, business name, lot number, usage dosage, but also marked "validity period: 36 months."
    but it's still misleading.
    the reason is that the lot number "200813", although "13" can not be the month, but "2008" will be easy to make people think of 2008.
    in fact, in the box packaging is a very detailed introduction, batch number, production date, expiration period.
    can be seen here, "20" in "200813" refers to 2020.
    for an enterprise, knowing the production lot number can be traced back to all the information.
    but for the end-users, the production date makes more sense than the lot number.
    directly related to "is this medicine eaten or thrown?" It can be said that many pharmaceutical labeling concepts, or all rely on the outer packaging.
    often overlook a point, after the box, many people do not retain the original packaging, only retain the basic unit of use.
    compliance is the first, but it is not enough to comply with regulations.
    after all, medicine is also a commodity, if customers have the ability to choose their own, will certainly buy a more humane brand.
    the production enterprises feel wronged? In fact, it is not wrong.
    design is also relying on people to find and implement, which can reflect the level of enterprises.
    when all products are a standard, then differentiated design concepts are a competitiveness.
    and this competitiveness does not depend on research and development, technology and other capabilities, is a type of low investment and high returns.
    don't say these corner corners are nothing, when the humanized design concept deeply rooted in the hearts of the people, will inevitably drive the enterprise's product visibility.
    this spillover value is the way to distinguish homogenized drugs.
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