Evidence map›Paper›PMID 34249396›Full record

ArticleJournal of pharmacopuncture2021

Quality Control of Pharmacopuncture: A Comparative Study of Good Manufacturing Practice and External Herbal Dispensary Standards.

Ji-Eun Han, Minjung Park, Tteul-E-Bom An, Jong-Hyun Park, Danny Oh, Kyeong Han Kim, Soo-Hyun Sung

Abstract read
In one paragraph

Article in Journal of pharmacopuncture, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Ji-Eun HanDepartment of Policy Development, National Development Institute of Korean Medicine, Seoul, Republic of Korea.ORCID https://orcid.org/0000-0001-9014-0354
Minjung ParkNational Agency for Development of Innovative Technologies in Korean Medicine, Seoul, Republic of Korea.ORCID https://orcid.org/0000-0003-2219-9666
Tteul-E-Bom AnKind Cloud Korean Medicine Clinic, Jinju, Republic of Korea.ORCID https://orcid.org/0000-0002-1045-0561
Jong-Hyun ParkDepartment of Pathology, College of Korean Medicine, Dae-Gu Haany University, Gyeongsan, Republic of Korea.ORCID https://orcid.org/0000-0002-7220-2328
Danny OhGrauate School of Social Welfare, Soongsil University, Seoul, Republic of Korea.ORCID https://orcid.org/0000-0001-8737-3210
Kyeong Han KimDepartment of Preventive Medicine, College of Korean Medicine, Woosuk University, Wanju, Republic of Korea.ORCID https://orcid.org/0000-0003-4868-9145
Soo-Hyun SungDepartment of Policy Development, National Development Institute of Korean Medicine, Seoul, Republic of Korea.ORCID https://orcid.org/0000-0001-7606-0147

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesWe aimed to compare the external herbal dispensary (EHD) evaluation criteria for pharmacopuncture and the Korea Good Manufacturing Practice (KGMP) sterile medicine standards to contribute to the establishment of quality control criteria for pharmacopuncture.

methodsWe obtained the KGMP standards from the Ministry of Food and Drug Safety and the pharmacopuncture certification criteria from the Ministry of Health and Welfare of South Korea. The EHD evaluation items were classified into three categories facilities, quality control, and validation. The evaluation items were compared with the KGMP sterile medicine criteria to determine their conformance with each other, followed by a discussion among the committee of six experts and their consensus to suggest the items to complement the EHD evaluation criteria.

resultsAmong the KGMP sterile medicine criteria, 44 were related to the management of the facilities, and 32 pharmacopuncture evaluation items corresponded to these KGMP items (66.7%). Fifty-eight KGMP criteria were related to quality management, and 42 pharmacopuncture evaluation items corresponded to these KGMP items (72.4%). Twenty-five KGMP sterile medicine criteria were related to validation, and 11 pharmacopuncture evaluation items corresponded to these KGMP items (44.0%). Sixteen items under the pharmacopuncture EHD criteria corresponded to the KGMP sterile medicine criteria based on the consent of the experts. Among these, 4 were related to facility management, 6 were related to quality control, and 6 were related to validation.

conclusionFor the safety and quality control of pharmacopuncture, there is a need to select the criteria for the mandatory items among the proposed pharmacopuncture-EHD criteria laws and systems to ensure that the pharmacopuncture materials are produced under the pharmacopuncture-EHD in compliance with the relevant requirements. More studies are needed to secure the safety level of pharmacopuncture materials corresponding to that of conventional medicine.

Indexed as

external herbal dispensarygood manufacturing practice (GMP)pharmacopuncturequality control

Identifiers

PMID34249396
PMCPMC8220506

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.