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Development and Delphi validation of instrument for the preparation of a GMP audit of a cosmetic contract manufacturer in the UAE
Outsourcing is rapidly increasing in the cosmetic industry. When cosmetic manufacturing activities are outsourced, product quality control and assurance procedures are important to guarantee the safety of the final products. One method to ensure the compliance of potential contract manufacturers wit...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Nature Publishing Group UK
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9253126/ https://www.ncbi.nlm.nih.gov/pubmed/35789167 http://dx.doi.org/10.1038/s41598-022-14457-7 |
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author | Jairoun, Ammar Abdulrahman Al-Hemyari, Sabaa Saleh Shahwan, Moyad El-Dahiyat, Faris Bisgwa, Justyna Jamshed, Shazia Shourrab, Hanady Yousef |
author_facet | Jairoun, Ammar Abdulrahman Al-Hemyari, Sabaa Saleh Shahwan, Moyad El-Dahiyat, Faris Bisgwa, Justyna Jamshed, Shazia Shourrab, Hanady Yousef |
author_sort | Jairoun, Ammar Abdulrahman |
collection | PubMed |
description | Outsourcing is rapidly increasing in the cosmetic industry. When cosmetic manufacturing activities are outsourced, product quality control and assurance procedures are important to guarantee the safety of the final products. One method to ensure the compliance of potential contract manufacturers with Good Manufacturing Practices (GMP) is auditing. Auditing can be confirmed by using GMP questionnaires. The current study aims to develop an effective instrument, in the form of a questionnaire, and to validate its content using the Delphi method. A modified Delphi method used an expert panel to develop a questionnaire-based audit preparation instrument. In the Delphi questionnaire round, 50 experts from cosmeceutical industries, relevant authorities, and universities assessed the content validity of the audit preparation instrument. The Delphi questionnaire round targeted 70 experts from the cosmetics industry; 50 completed the questionnaire, giving a response rate of 71.4%. Their agreement level on the quality of the instrument items ranged between 56 and 96%. Of the 52 items, 47 (90.4%) met the predefined criterion for an agreement rate of at least 75%. The proposed audit preparation instrument demonstrated good content validity, and the expert panel participating in the Delphi questionnaire round made a few minor suggestions for modifications. The modified Delphi method used for the content validation of the instrument proved to be suitable. However, based on the panel’s feedback, additional research is needed to ensure the maximum applicability and practicality of the instrument. |
format | Online Article Text |
id | pubmed-9253126 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Nature Publishing Group UK |
record_format | MEDLINE/PubMed |
spelling | pubmed-92531262022-07-06 Development and Delphi validation of instrument for the preparation of a GMP audit of a cosmetic contract manufacturer in the UAE Jairoun, Ammar Abdulrahman Al-Hemyari, Sabaa Saleh Shahwan, Moyad El-Dahiyat, Faris Bisgwa, Justyna Jamshed, Shazia Shourrab, Hanady Yousef Sci Rep Article Outsourcing is rapidly increasing in the cosmetic industry. When cosmetic manufacturing activities are outsourced, product quality control and assurance procedures are important to guarantee the safety of the final products. One method to ensure the compliance of potential contract manufacturers with Good Manufacturing Practices (GMP) is auditing. Auditing can be confirmed by using GMP questionnaires. The current study aims to develop an effective instrument, in the form of a questionnaire, and to validate its content using the Delphi method. A modified Delphi method used an expert panel to develop a questionnaire-based audit preparation instrument. In the Delphi questionnaire round, 50 experts from cosmeceutical industries, relevant authorities, and universities assessed the content validity of the audit preparation instrument. The Delphi questionnaire round targeted 70 experts from the cosmetics industry; 50 completed the questionnaire, giving a response rate of 71.4%. Their agreement level on the quality of the instrument items ranged between 56 and 96%. Of the 52 items, 47 (90.4%) met the predefined criterion for an agreement rate of at least 75%. The proposed audit preparation instrument demonstrated good content validity, and the expert panel participating in the Delphi questionnaire round made a few minor suggestions for modifications. The modified Delphi method used for the content validation of the instrument proved to be suitable. However, based on the panel’s feedback, additional research is needed to ensure the maximum applicability and practicality of the instrument. Nature Publishing Group UK 2022-07-04 /pmc/articles/PMC9253126/ /pubmed/35789167 http://dx.doi.org/10.1038/s41598-022-14457-7 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Article Jairoun, Ammar Abdulrahman Al-Hemyari, Sabaa Saleh Shahwan, Moyad El-Dahiyat, Faris Bisgwa, Justyna Jamshed, Shazia Shourrab, Hanady Yousef Development and Delphi validation of instrument for the preparation of a GMP audit of a cosmetic contract manufacturer in the UAE |
title | Development and Delphi validation of instrument for the preparation of a GMP audit of a cosmetic contract manufacturer in the UAE |
title_full | Development and Delphi validation of instrument for the preparation of a GMP audit of a cosmetic contract manufacturer in the UAE |
title_fullStr | Development and Delphi validation of instrument for the preparation of a GMP audit of a cosmetic contract manufacturer in the UAE |
title_full_unstemmed | Development and Delphi validation of instrument for the preparation of a GMP audit of a cosmetic contract manufacturer in the UAE |
title_short | Development and Delphi validation of instrument for the preparation of a GMP audit of a cosmetic contract manufacturer in the UAE |
title_sort | development and delphi validation of instrument for the preparation of a gmp audit of a cosmetic contract manufacturer in the uae |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9253126/ https://www.ncbi.nlm.nih.gov/pubmed/35789167 http://dx.doi.org/10.1038/s41598-022-14457-7 |
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