echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Medical World News > The ointment that the drugmaker bought broke the milk manufacturer's response lit up or cool?

    The ointment that the drugmaker bought broke the milk manufacturer's response lit up or cool?

    • Last Update: 2021-01-18
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    the | Lao Xue, do you think the quality of the medicine is qualified? Recently, a pharmaceutical netizen broke the news that a pharmaceutical company bought snow glycoside cream ointment presents emulsion-like - "newly bought before the bottle opened the shaking energy can clearly hear the sound of liquid flow."
    " manufacturers reply that this is after the drug supervision system inspection, does not affect the quality.
    " now bought the product is already the state of liquid, to the manufacturer to call the past, quality personnel explained that because before September 2020 commissioned production, expand the batch of production in accordance with the original process parameters, quality personnel explained that the key testing items meet the requirements, but the status is inconsistent with the original, does not affect the effect of the drug, only because of the expansion of the batch, the use of the original parameters lead to product thinning, and the original product is not the same, this operation also passed xx province and XX province of some departments of GMP inspection.
    " source: dandelion forum as a comment, we can not do to verify the authenticity.
    , but based on the affirmation of the professional quality of the pharmaceutical person, we based this event on a real perspective to do an analysis.
    this drug should be in what form? After searching for "snow glycoside cream ointment", it was found that its implementation standard is the Ministry of Health of Chinese medicine prescription preparation Volume 13, standard number: WS3-B-2598-97.
    found this standard independent of pharmacopeia.
    is clearly "white ointment" in the column on the same sex.
    since the rule is "ointment", then you made a lotion, certainly not in line with the project.
    this, no matter who gave you the GMP check, can not be used as a basis to change the product features.
    you re-register a product and the registration standard can no longer be labeled "WS3-B-2598-97".
    to do it when you mark it, it's an industry general rules.
    and under the "inspection" item, reference was also made to "compliance with the relevant provisions under ointments".
    we didn't find this Appendix I R, but there's an ointment item in the pharmacopeia that shouldn't make much difference.
    pharmacopeia describes ointments as "a uniform semi-solid external preparation made by mixing the API with an oily or water-soluble substate".
    from this point of view, regardless of whether the enterprise truthfully described "with the original product characteristics are not the same, this operation also passed the xx province and XX province of some departments of the GMP inspection", are not listed for sale.
    ointment into emulsion, is there any effect? How exactly a drug's sexuality should be done, personally believed to be often constrained by two factors.
    is stability.
    we know a lot of injections, some freeze-dried powder, some directly liquid.
    and freeze-dried powder in the preparation process is also made into a liquid first, why not directly save the freeze-dried process? Because of stability, some preparations are particularly sensitive to some factors, such as moisture, so it must be freeze-dried to remove moisture.
    is the use, or the way of dosing.
    such as your injections, to make capsules, will certainly increase the application of the process of operation.
    such as your oral agent, do not have to make vaginal supposition look, that is, there is perversion.
    we went back to this snow-covered cream ointment, and after looking at the instructions, the usage amount was "external, coated."
    that emulsions have no effect on drug effectiveness, what about the process of use? Must have an impact, at least we know that toothpaste can stick to the toothbrush, the most important point is that the paste has a similar fixed holding effect.
    and the lotion is applied, the probability is to decline.
    ointment into emulsion, what's the problem? In fact, enterprises are well aware of the problem.
    " commissioned production, the expansion of batch production in accordance with the original process parameters, quality personnel explained that the key test items meet the requirements, but the nature and the original inconsistent, does not affect the ability of the drug, only because of the expansion of the batch, the use of the original parameters lead to the product is too thin, and the original product's nature is not the same."
    a word, that is, the process did not follow the scale, resulting in product adverse.
    , according to the industry, this is "broken milk".
    may be a formulation substation problem or a production process problem.
    the current practice of enterprises, is undoubtedly to add to their own trouble.
    not to solve the problem, but to cover up the problem, but also to use the regulator to block the arrow, is wrong.
    if the ointment is made into emulsion, it can really be called "paste", then the way to shirk responsibility is really "high".
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.