Basic good manufacturing practices (GMP), special conditions and inspection processes in the Covid19 (SARS-CoV-2) pandemic

Abdullah Levent Alparslan

doi:10.29228/jrp.247

Derleme

Yıl 2022, Cilt: 26 Sayı: 6, 1527 - 1538, 28.06.2025

Abdullah Levent Alparslan

https://doi.org/10.29228/jrp.247

Öz

Kaynakça

1. WHO good manufacturing practices for pharmaceutical products: Main principles. Annex 2, WHO Technical Report Series 986, 2014 https://www.who.int/publications/m/item/who-good-manufacturing-practices-for-pharmaceutical-products-main-principles-a
2. Guidance for Industry Cosmetic Good Manufacturing Practices FDA, Draft, February 12, 1997; revised April 24, 2008 and June 2013 https://www.fda.gov/files/cosmetics/published/Guidance-for-Indiustry--Cosmetic-Good-Manufacturing-Practices-PDF.pdf
3. ISO 22716:2007 Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices, EU; Publication date : 2007-11 http://www.kpairan.com/gmp.pdf
4. CDC. Check and record everyday (CARE). August 25, 2021 https://www.cdc.gov/coronavirus/2019-ncov/travelers/after-travel-precautions.html
5. CDC. Symptoms of coronavirus. May 13, 2020 https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html
6. FBIA. Screening food industry employees for COVID-19 symptoms or exposure. March 30, 2020 Version 1.0 https://fil-idf.org/wp-content/uploads/2020/04/EmployeeScreening-20200330_draftfinal002_SIGNED.pdf
7. WHO. COVID-19 and food safety: Guidance for food businesses: Interim guidance, April 07, 2020 https://www.who.int/publications/i/item/covid-19-and-food-safety-guidance-for-food-businesses
8. Todd EC, Michaels BS, Smith D, Greig JD, Bartleson CA. Outbreaks where food workers have been implicated in the spread of foodborne disease. J Food Prot. 2010;73(10):1937-55. [CrossRef]
9. Fuls JL, Rodgers ND, Fischler GE, et al. Alternative hand contamination technique to compare soaps. Appl Environ Microbiol. 2008;74(12):3739-44. [CrossRef]
10. Jensen D, Danyluk M, Harris L, Schaffner D. Effect of hand wash on removal of bacteria. J Food Prot. 2015 Apr;78(4):685-690. [CrossRef]
11. Edmonds SL, Mann J, McCormack RR, et al. SaniTwice: a novel approach to hand hygiene. J Food Prot. 2010 Dec;73(12):2296-300. [CrossRef]
12. Grayson ML, Melvani S, Druce J, et al. Efficacy of soap and water and alcohol-based hand rubs. Clin Infect Dis. 2009;48(3):285-91. doi:10.1086/595845 [CrossRef]
13. FDA Q&A for consumers: Hand sanitizers and COVID-19. December 15, 2020 https://www.fda.gov/drugs/information-drug-class/qa-consumers-hand-sanitizers-and-covid-19
14. CDC. Guidance for Wearing Masks Help Slow the Spread of COVID-19. April 19, 2021 https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/cloth-face-cover-guidance.html
15. WHO. When and how to use masks. December 1, 2020 https://www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public/when-and-how-to-use-masks
16. Barbosa MH, Graziano KU. Efficacy of disposable surgical masks as microbial barrier. Braz J Microbiol. 2006;37:216-217 [CrossRef]
17. WHO. Coronavirus disease (COVID-19) https://www.who.int/health-topics/coronavirus#tab=tab_1
18. CDC. How COVID-19 spreads? July 14, 2021 https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html
19. IDFA. Emergency Prevention Measures in Food Manufacturing. March 31, 2020 https://fil-idf.org/wp-content/uploads/2020/04/2020-03-31-Emergency-Preventions-Measures-for-Physical-Distancing-in-Food-Manufacturing-as-Related-to-COVID-19.pdf
20. CDC. Interim US guidance for risk assessment and public health management. March 7, 2020 https://stacks.cdc.gov/view/cdc/85723
21. WHO. GMP for HVAC in non-sterile dosage forms. Technical Report Series, No. 961, 2011 https://gmpsop.com/RegulatoryReference/WHO/GMP_for_heating__ventilation_and_air_conditioning_for_non_sterile_pharmaceutical_dosage_form.pdf
22. TİTCK. Beşeri Tıbbi Ürünler İmalathaneleri GMP Kılavuzu Versiyon: 2018/02 https://titck.gov.tr/storage/Archive/2019/legislation/14ebd0e9-2378-491a-9c4a-27e749a82204.pdf
23. T.C. Sağlık Bakanlığı. COVID-19 Salgın Yönetimi ve Çalışma Rehberi. 6 Eylül 2021 https://maltepe.edu.tr/Content/Media/Announcement/11102021092134025-covid19-toplumdasalginyonetimirehberipdf.pdf
24. WHO. COVID-19 and food safety: Guidance for food businesses. April 7, 2020 https://www.who.int/publications/i/item/covid-19-and-food-safety-guidance-for-food-businesses
25. WHO. Good manufacturing practices: Water for pharmaceutical use. Working doc QAS/20.842. May 2020 https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS20_842_gmp_water_for_pharmaceutical_use.pdf
26. EMA. Guideline on the quality of water for pharmaceutical use. 20 July 2020 https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-water-pharmaceutical-use_en.pdf
27. CDC. Food safety and COVID-19. June 22, 2020 https://www.cdc.gov/foodsafety/newsletter/food-safety-and-Coronavirus.html
28. Kampf G, Todt D, Pfaenders S, Steinmann E. Persistence of Coronaviruses and their inactivation. J Hosp Infect. 2020;104(3):246–251 [CrossRef]
29. EU Commission. EudraLex Volume 4 GMP for Human and Veterinary Use Annex 16. October 12, 2015 https://ec.europa.eu/health/system/files/2016-11/v4_an16_201510_en_0.pdf
30. FDA. Small Entity Compliance Guide for Dietary Supplements. December 2010 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-current-good-manufacturing-practice-manufacturing-packaging-labeling
31. Asean Guidelines For Cosmetic Good Manufacturing Practice. Appendix VI https://www.hsa.gov.sg/docs/default-source/hprg/cosmetic-products/guidance/appendix-vi-(asean-guidelines-for-cosmetic-good-manufacturing-practices).pdf
32. Guide to Good Manufacturing Practice of Cosmetic Products. Health Products Regulatory Authority (HPRA), Ireland. IA-G0048-2, 2 April 2016 https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/guide-to-good-manufacturing-practice-of-cosmetic-products.pdf?sfvrsn=9
33. EPA. Frequent questions about disinfectants and coronavirus (COVID-19). April 29, 2020 https://www.epa.gov/coronavirus/frequent-questions-about-disinfectants-and-coronavirus-covid-19
34. EPA. List N: Disinfectants for use against SARS-CoV-2. May 28, 2020 https://www.epa.gov/coronavirus/about-list-n-disinfectants-coronavirus-covid-19-0
35. Guidance for the public on the mental health and wellbeing aspects of coronavirus (COVID-19). March 31, 2020 https://www.gov.uk/government/publications/covid-19-guidance-for-the-public-on-mental-health-and-wellbeing/guidance-for-the-public-on-the-mental-health-and-wellbeing-aspects-of-coronavirus-covid19
36. Gouveia BG, Rijo P, Goncalo TS, Reis CP. Good manufacturing practices for medicinal products for human use. J Pharm Bioallied Sci. 2015;7(2):87–96 [CrossRef]
37. PIC/S. Guide To Good Manufacturing Practice For Medicinal Products Annexes. PE 009-15 (Annex 13), 1 May 2021 https://picscheme.org/docview/4590
38. FDA. COVID-19 Update: FDA Outlines Inspection and Assessment Activities During Pandemic. May 05, 2021 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-outlines-inspection-and-assessment-activities-during-pandemic
39. TGA. Domestic Good Manufacturing Practice (GMP) inspections during the COVID-19 pandemic. August 24, 2021 https://www.tga.gov.au/media-release/domestic-good-manufacturing-practice-gmp-inspections-during-covid-19-pandemic
40. EFPIA. Alternative GMP/GDP Inspection Practices in a Pandemic Situation (COVID‐19) and Beyond. May 28, 2020 https://www.efpia.eu/media/547487/alternative-gmp-gdp-inspection-practices-in-a-pandemic-situation-covid-19-and-beyond.pdf
41. PIC/S. COVID-19 Risk Assessment For National Routine On-Site Inspections. 15 July 2021 https://picscheme.org/docview/4295
42. EMA. Update to guidance on regulatory expectations in the context of COVID-19 pandemic. April 20, 2020 https://www.ema.europa.eu/en/news/update-guidance-regulatory-expectations-context-covid-19-pandemic
43. TİTCK. Yurt Dışı GMP Denetimleri ve Sertifikasyon Süreçleri Hakkında Pandemi Sürecinde Uygulanacak Ek Tedbirler. 12 Haziran 2020 https://www.titck.gov.tr/duyuru/yurt-disi-gmp-denetimleri-ve-sertifikasyon-surecleri-hakkinda-pandemi-surecinde-uygulanacak-ek-tedbirler-12062020173517
44. EudraLex - Volume 4 - GMP guidelines. Chapter 9: Self Inspection https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-4/pdfs-en/cap9_en.pdf
45. PIC/S. Guide To GMP For Medicinal Products Annexes. PE 009-15 (Annex 11), 1 May 2021 https://picscheme.org/en/news/revision-of-pics-gmp-guide-pe-009-15
46. WHO. Annex 3 - WHO GMP for Pharmaceutical Products: Main Principles, Self-inspection, Quality Audits. WHO Technical Report Series, No. 961, 2011 https://www.who.int/medicines/areas/quality_safety/quality_assurance/GMPPharmaceuticalProductsMainPrinciplesTRS961Annex3.pdf

Basic good manufacturing practices (GMP), special conditions and inspection processes in the Covid19 (SARS-CoV-2) pandemic

Yıl 2022, Cilt: 26 Sayı: 6, 1527 - 1538, 28.06.2025

Abdullah Levent Alparslan

https://doi.org/10.29228/jrp.247

Öz

The COVID-19 pandemic has severely impacted the world economy, businesses and global health. Exceptional situations are evident in the food, cosmetics and pharmaceutical production in the supply chain, where many businesses have been shut down completely following government restrictions. In the pandemic process, it has become much more important to ensure hygienic products and employee safety and to deliver quality and healthy products to the consumer. In extraordinary conditions, it is necessary to provide additional contributions to the principles of good manufacturing practices. With the additional measures to be taken during the epidemic period, a healthy and safe operation can be brought to production. In addition, the assurance system can continue to function despite restrictions and failing audits. In addition to the updated guides, the development of roadmaps specific to the epidemic period for production may provide the advantage of being ready for problems.

Anahtar Kelimeler

Covid19, GMP, GDP, production, inspecion, guide, SARS-CoV-2

Kaynakça

1. WHO good manufacturing practices for pharmaceutical products: Main principles. Annex 2, WHO Technical Report Series 986, 2014 https://www.who.int/publications/m/item/who-good-manufacturing-practices-for-pharmaceutical-products-main-principles-a
2. Guidance for Industry Cosmetic Good Manufacturing Practices FDA, Draft, February 12, 1997; revised April 24, 2008 and June 2013 https://www.fda.gov/files/cosmetics/published/Guidance-for-Indiustry--Cosmetic-Good-Manufacturing-Practices-PDF.pdf
3. ISO 22716:2007 Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices, EU; Publication date : 2007-11 http://www.kpairan.com/gmp.pdf
4. CDC. Check and record everyday (CARE). August 25, 2021 https://www.cdc.gov/coronavirus/2019-ncov/travelers/after-travel-precautions.html
5. CDC. Symptoms of coronavirus. May 13, 2020 https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html
6. FBIA. Screening food industry employees for COVID-19 symptoms or exposure. March 30, 2020 Version 1.0 https://fil-idf.org/wp-content/uploads/2020/04/EmployeeScreening-20200330_draftfinal002_SIGNED.pdf
7. WHO. COVID-19 and food safety: Guidance for food businesses: Interim guidance, April 07, 2020 https://www.who.int/publications/i/item/covid-19-and-food-safety-guidance-for-food-businesses
8. Todd EC, Michaels BS, Smith D, Greig JD, Bartleson CA. Outbreaks where food workers have been implicated in the spread of foodborne disease. J Food Prot. 2010;73(10):1937-55. [CrossRef]
9. Fuls JL, Rodgers ND, Fischler GE, et al. Alternative hand contamination technique to compare soaps. Appl Environ Microbiol. 2008;74(12):3739-44. [CrossRef]
10. Jensen D, Danyluk M, Harris L, Schaffner D. Effect of hand wash on removal of bacteria. J Food Prot. 2015 Apr;78(4):685-690. [CrossRef]
11. Edmonds SL, Mann J, McCormack RR, et al. SaniTwice: a novel approach to hand hygiene. J Food Prot. 2010 Dec;73(12):2296-300. [CrossRef]
12. Grayson ML, Melvani S, Druce J, et al. Efficacy of soap and water and alcohol-based hand rubs. Clin Infect Dis. 2009;48(3):285-91. doi:10.1086/595845 [CrossRef]
13. FDA Q&A for consumers: Hand sanitizers and COVID-19. December 15, 2020 https://www.fda.gov/drugs/information-drug-class/qa-consumers-hand-sanitizers-and-covid-19
14. CDC. Guidance for Wearing Masks Help Slow the Spread of COVID-19. April 19, 2021 https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/cloth-face-cover-guidance.html
15. WHO. When and how to use masks. December 1, 2020 https://www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public/when-and-how-to-use-masks
16. Barbosa MH, Graziano KU. Efficacy of disposable surgical masks as microbial barrier. Braz J Microbiol. 2006;37:216-217 [CrossRef]
17. WHO. Coronavirus disease (COVID-19) https://www.who.int/health-topics/coronavirus#tab=tab_1
18. CDC. How COVID-19 spreads? July 14, 2021 https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html
19. IDFA. Emergency Prevention Measures in Food Manufacturing. March 31, 2020 https://fil-idf.org/wp-content/uploads/2020/04/2020-03-31-Emergency-Preventions-Measures-for-Physical-Distancing-in-Food-Manufacturing-as-Related-to-COVID-19.pdf
20. CDC. Interim US guidance for risk assessment and public health management. March 7, 2020 https://stacks.cdc.gov/view/cdc/85723
21. WHO. GMP for HVAC in non-sterile dosage forms. Technical Report Series, No. 961, 2011 https://gmpsop.com/RegulatoryReference/WHO/GMP_for_heating__ventilation_and_air_conditioning_for_non_sterile_pharmaceutical_dosage_form.pdf
22. TİTCK. Beşeri Tıbbi Ürünler İmalathaneleri GMP Kılavuzu Versiyon: 2018/02 https://titck.gov.tr/storage/Archive/2019/legislation/14ebd0e9-2378-491a-9c4a-27e749a82204.pdf
23. T.C. Sağlık Bakanlığı. COVID-19 Salgın Yönetimi ve Çalışma Rehberi. 6 Eylül 2021 https://maltepe.edu.tr/Content/Media/Announcement/11102021092134025-covid19-toplumdasalginyonetimirehberipdf.pdf
24. WHO. COVID-19 and food safety: Guidance for food businesses. April 7, 2020 https://www.who.int/publications/i/item/covid-19-and-food-safety-guidance-for-food-businesses
25. WHO. Good manufacturing practices: Water for pharmaceutical use. Working doc QAS/20.842. May 2020 https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS20_842_gmp_water_for_pharmaceutical_use.pdf
26. EMA. Guideline on the quality of water for pharmaceutical use. 20 July 2020 https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-water-pharmaceutical-use_en.pdf
27. CDC. Food safety and COVID-19. June 22, 2020 https://www.cdc.gov/foodsafety/newsletter/food-safety-and-Coronavirus.html
28. Kampf G, Todt D, Pfaenders S, Steinmann E. Persistence of Coronaviruses and their inactivation. J Hosp Infect. 2020;104(3):246–251 [CrossRef]
29. EU Commission. EudraLex Volume 4 GMP for Human and Veterinary Use Annex 16. October 12, 2015 https://ec.europa.eu/health/system/files/2016-11/v4_an16_201510_en_0.pdf
30. FDA. Small Entity Compliance Guide for Dietary Supplements. December 2010 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-current-good-manufacturing-practice-manufacturing-packaging-labeling
31. Asean Guidelines For Cosmetic Good Manufacturing Practice. Appendix VI https://www.hsa.gov.sg/docs/default-source/hprg/cosmetic-products/guidance/appendix-vi-(asean-guidelines-for-cosmetic-good-manufacturing-practices).pdf
32. Guide to Good Manufacturing Practice of Cosmetic Products. Health Products Regulatory Authority (HPRA), Ireland. IA-G0048-2, 2 April 2016 https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/guide-to-good-manufacturing-practice-of-cosmetic-products.pdf?sfvrsn=9
33. EPA. Frequent questions about disinfectants and coronavirus (COVID-19). April 29, 2020 https://www.epa.gov/coronavirus/frequent-questions-about-disinfectants-and-coronavirus-covid-19
34. EPA. List N: Disinfectants for use against SARS-CoV-2. May 28, 2020 https://www.epa.gov/coronavirus/about-list-n-disinfectants-coronavirus-covid-19-0
35. Guidance for the public on the mental health and wellbeing aspects of coronavirus (COVID-19). March 31, 2020 https://www.gov.uk/government/publications/covid-19-guidance-for-the-public-on-mental-health-and-wellbeing/guidance-for-the-public-on-the-mental-health-and-wellbeing-aspects-of-coronavirus-covid19
36. Gouveia BG, Rijo P, Goncalo TS, Reis CP. Good manufacturing practices for medicinal products for human use. J Pharm Bioallied Sci. 2015;7(2):87–96 [CrossRef]
37. PIC/S. Guide To Good Manufacturing Practice For Medicinal Products Annexes. PE 009-15 (Annex 13), 1 May 2021 https://picscheme.org/docview/4590
38. FDA. COVID-19 Update: FDA Outlines Inspection and Assessment Activities During Pandemic. May 05, 2021 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-outlines-inspection-and-assessment-activities-during-pandemic
39. TGA. Domestic Good Manufacturing Practice (GMP) inspections during the COVID-19 pandemic. August 24, 2021 https://www.tga.gov.au/media-release/domestic-good-manufacturing-practice-gmp-inspections-during-covid-19-pandemic
40. EFPIA. Alternative GMP/GDP Inspection Practices in a Pandemic Situation (COVID‐19) and Beyond. May 28, 2020 https://www.efpia.eu/media/547487/alternative-gmp-gdp-inspection-practices-in-a-pandemic-situation-covid-19-and-beyond.pdf
41. PIC/S. COVID-19 Risk Assessment For National Routine On-Site Inspections. 15 July 2021 https://picscheme.org/docview/4295
42. EMA. Update to guidance on regulatory expectations in the context of COVID-19 pandemic. April 20, 2020 https://www.ema.europa.eu/en/news/update-guidance-regulatory-expectations-context-covid-19-pandemic
43. TİTCK. Yurt Dışı GMP Denetimleri ve Sertifikasyon Süreçleri Hakkında Pandemi Sürecinde Uygulanacak Ek Tedbirler. 12 Haziran 2020 https://www.titck.gov.tr/duyuru/yurt-disi-gmp-denetimleri-ve-sertifikasyon-surecleri-hakkinda-pandemi-surecinde-uygulanacak-ek-tedbirler-12062020173517
44. EudraLex - Volume 4 - GMP guidelines. Chapter 9: Self Inspection https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-4/pdfs-en/cap9_en.pdf
45. PIC/S. Guide To GMP For Medicinal Products Annexes. PE 009-15 (Annex 11), 1 May 2021 https://picscheme.org/en/news/revision-of-pics-gmp-guide-pe-009-15
46. WHO. Annex 3 - WHO GMP for Pharmaceutical Products: Main Principles, Self-inspection, Quality Audits. WHO Technical Report Series, No. 961, 2011 https://www.who.int/medicines/areas/quality_safety/quality_assurance/GMPPharmaceuticalProductsMainPrinciplesTRS961Annex3.pdf

Toplam 46 adet kaynakça vardır.

Ayrıntılar

Birincil Dil	İngilizce
Konular	Eczacılık ve İlaç Bilimleri (Diğer)
Bölüm	Reviews
Yazarlar	Abdullah Levent Alparslan
Yayımlanma Tarihi	28 Haziran 2025
Yayımlandığı Sayı	Yıl 2022 Cilt: 26 Sayı: 6

Kaynak Göster

APA	Alparslan, A. L. (2025). Basic good manufacturing practices (GMP), special conditions and inspection processes in the Covid19 (SARS-CoV-2) pandemic. Journal of Research in Pharmacy, 26(6), 1527-1538. https://doi.org/10.29228/jrp.247
AMA	Alparslan AL. Basic good manufacturing practices (GMP), special conditions and inspection processes in the Covid19 (SARS-CoV-2) pandemic. J. Res. Pharm. Haziran 2025;26(6):1527-1538. doi:10.29228/jrp.247
Chicago	Alparslan, Abdullah Levent. “Basic Good Manufacturing Practices (GMP), Special Conditions and Inspection Processes in the Covid19 (SARS-CoV-2) Pandemic”. Journal of Research in Pharmacy 26, sy. 6 (Haziran 2025): 1527-38. https://doi.org/10.29228/jrp.247.
EndNote	Alparslan AL (01 Haziran 2025) Basic good manufacturing practices (GMP), special conditions and inspection processes in the Covid19 (SARS-CoV-2) pandemic. Journal of Research in Pharmacy 26 6 1527–1538.
IEEE	A. L. Alparslan, “Basic good manufacturing practices (GMP), special conditions and inspection processes in the Covid19 (SARS-CoV-2) pandemic”, J. Res. Pharm., c. 26, sy. 6, ss. 1527–1538, 2025, doi: 10.29228/jrp.247.
ISNAD	Alparslan, Abdullah Levent. “Basic Good Manufacturing Practices (GMP), Special Conditions and Inspection Processes in the Covid19 (SARS-CoV-2) Pandemic”. Journal of Research in Pharmacy 26/6 (Haziran 2025), 1527-1538. https://doi.org/10.29228/jrp.247.
JAMA	Alparslan AL. Basic good manufacturing practices (GMP), special conditions and inspection processes in the Covid19 (SARS-CoV-2) pandemic. J. Res. Pharm. 2025;26:1527–1538.
MLA	Alparslan, Abdullah Levent. “Basic Good Manufacturing Practices (GMP), Special Conditions and Inspection Processes in the Covid19 (SARS-CoV-2) Pandemic”. Journal of Research in Pharmacy, c. 26, sy. 6, 2025, ss. 1527-38, doi:10.29228/jrp.247.
Vancouver	Alparslan AL. Basic good manufacturing practices (GMP), special conditions and inspection processes in the Covid19 (SARS-CoV-2) pandemic. J. Res. Pharm. 2025;26(6):1527-38.

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