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