echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Latest Medical News > The construction of the standard system of pharmaceutical packaging materials in the Chinese Pharmacopoeia has entered an intensive publicity period, and the National Pharmacopoeia Commission has issued 3 more announcements!

    The construction of the standard system of pharmaceutical packaging materials in the Chinese Pharmacopoeia has entered an intensive publicity period, and the National Pharmacopoeia Commission has issued 3 more announcements!

    • Last Update: 2023-02-02
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

    On January 4, the National Pharmacopoeia Commission announced the draft of two general standards for prefilled syringes, nine draft standards for general detection methods for prefilled syringes, and draft standards for the determination of insoluble particles in pharmaceutical packaging materials
    .
    This is the second time that the National Pharmacopoeia Commission has publicized the draft standards related to pharmaceutical packaging materials after the announcement of the "Guidelines for the Biological Evaluation and Test Selection of Pharmaceutical Packaging Materials" on November 21 last year, which also means that the construction of the standard system of pharmaceutical packaging materials in the Chinese Pharmacopoeia is about to enter an intensive publicity period
    .

    The draft standard published this time was publicly solicited on the official website of the National Pharmacopoeia Commission on July 11 last year, and in July 1On the 8th, it entered the first round of comments list of the first batch of 46 draft pharmaceutical packaging materials
    .

    According to the general idea of the revision of pharmacopoeia standards for pharmaceutical packaging materials, the standard system of prefilled syringes involves 3 special general rules, 5 related general principles, 5 guiding principles and 13 supporting general detection methods
    .
    The draft standard for prefilled syringes published this time includes two special general rules, including the draft general rules for prefilled syringes and the draft general rules for semi-assembled prefilled syringes, as well as nine general test method standards such as the prefilled syringe Luer cone joint inspection method and the prefilled syringe cap and sleeve tightness inspection method
    .


    In the draft of this announcement, the determination method of insoluble particles in pharmaceutical packaging materials includes photoobscuration method and microscopic counting method to determine the size and number of insoluble particles in pharmaceutical packaging materials, including rubber stoppers for injection packaging, plastic containers for injection (plastic infusion bottles and infusion bags), inner caps and interfaces for plastic infusion containers, pistons for no-wash prefilled syringes, pistons for no-wash pen syringes, semi-assembled prefilled syringes, pen syringe prefilling systems, plastic bottles for eye drops, and BFS

    For details, please click [Read Original] to view
    .


    Regarding the public number of the draft of the two general rules standards for prefilled syringes: FG2022-0249 Our committee intends to formulate the relevant general rules for prefilled syringes, in order to ensure the scientificity, rationality and applicability of the standards, the proposed standards are now publicized to solicit opinions from all walks of life (see the
    annex for details).

    The publicity period is 3 months
    from the date of publication.
    Please carefully review, if there is any objection, please submit feedback in time, with relevant instructions, experimental data and contact information
    .
    The relevant letter must be stamped with an official seal, and the personal letter must be signed by the person in person, and the electronic version should be sent to the designated email address
    .

    Contact: Chen Lei, Kang Xiaobo Tel: 010-67079566, 67079620 E-mail: 475@chp.
    org.
    cn
    Mailing address: Office of the National Pharmacopoeia Commission, Building 11, Fahua Nanli, Dongcheng District, Beijing Zip code: 100061 National Pharmacopoeia Commission 2023-01-04 identification QR code view attachment
    on the draft
    of 9 general detection methods for prefilled syringes No.
    : FG2022-0245
    Our committee plans to formulate a standard for general detection methods for prefilled syringes, in order to ensure the scientificity, rationality and applicability of the standard, the proposed standard is now publicized to solicit opinions from all walks of life (see annex for details).

    The publicity period is 3 months
    from the date of publication.
    Please carefully review, if there is any objection, please submit feedback in time, with relevant instructions, experimental data and contact information
    .
    The relevant letter must be stamped with an official seal, and the personal letter must be signed by the person in person, and the electronic version should be sent to the designated email address
    .

    Contact: Chen Lei, Kang Xiaobo Tel: 010-67079566, 67079620 E-mail: 475@chp.
    org.
    cn
    Mailing address: Office of the National Pharmacopoeia Commission, Building 11, Fahua Nanli, Dongcheng District, Beijing Zip code: 100061 National Pharmacopoeia Commission 2023-01-04 identification QR code view attachment
    on the draft standard for the determination of
    insoluble particles in pharmaceutical packaging materials No.
    : FG2022-0244
    Our committee plans to formulate standards for the determination of insoluble particles in pharmaceutical packaging materials, in order to ensure the scientificity, rationality and applicability of the standards, the proposed standards are now publicized to solicit opinions from all walks of life (see attachment for details).

    The publicity period is 3 months
    from the date of publication.
    Please carefully review, if there is any objection, please submit feedback in time, with relevant instructions, experimental data and contact information
    .
    The relevant letter must be stamped with an official seal, and the personal letter must be signed by the person in person, and the electronic version should be sent to the designated email address
    .

    Contact: Chen Lei, Kang Xiaobo Tel: 010-67079566, 67079620 E-mail: 475@chp.
    org.
    cn
    Mailing address: Office of the National Pharmacopoeia Commission, Building 11, Fahua Nanli, Dongcheng District, Beijing Zip code: 100061 National Pharmacopoeia Commission 2023-01-04 identification QR code viewing attachment
    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.