tetano
Editor, Senior Moderator
PDA J Pharm Sci Technol
. 2020 May 28;pdajpst.2020.012021.
doi: 10.5731/pdajpst.2020.012021. Online ahead of print.
CONTROLS TO MINIMIZE DISRUPTION OF THE PHARMACEUTICAL SUPPLY CHAIN DURING THE COVID-19 PANDEMIC
Anthony M Cundell[SUP] 1 [/SUP], Dennis Edward Guilfoyle[SUP] 2 [/SUP], T R Kreil[SUP] 3 [/SUP], Anil Sawant[SUP] 4 [/SUP]
Affiliations
Abstract
This article reviews currently available scientific literature related to the epidemiology, infectivity, survival, and susceptibility to disinfectants of Coronaviruses, in the context of the controls established to meet Good Manufacturing Practice regulations and guidance, and the public health guidance issued specifically to combat the Covid-19 pandemic. The possible impact of the COVID-19 pandemic on the pharmaceutical supply chain is assessed and recommendations are listed for risk mitigation steps to minimize supply disruption to pharmaceutical drug products. Areas addressed include a brief history of the COVID-19 viral pandemic, a description of the virus, the regulatory response to the pandemic, the screening of employees, the persistence on inanimate surfaces, cleaning and disinfection of manufacturing facilities, use of GMP-mandated personal protective equipment to counter the spread of the disease, the role of air changes in viral clearance, approaches to risk assessment and mitigation. Biological medicinal products have a great record of safety, yet the cell cultures used for production can be susceptible to viruses, and contamination events have occurred. Studies on SARS-CoV-1 for its ability to replicate in various mammalian cell lines used for biopharmaceutical manufacturing suggest SARS-CoV-2 poses low risk and any contamination would be detected by currently used adventitious virus testing. The consequences of the potential virus exposure of manufacturing processes, as well as the effectiveness of mitigation efforts are discussed. The pharmaceutical supply chain is complex, traversing many geographies and companies that range from large multinationals to mid and small size operations. This paper recommends practices that can be adopted by all companies, irrespective of their size, geographic location, or position in the supply chain.
Keywords: COVID-19 pandemic; SARS-CoV-2; drug shortage; risk assessment; risk mitigation; supply chain.
. 2020 May 28;pdajpst.2020.012021.
doi: 10.5731/pdajpst.2020.012021. Online ahead of print.
CONTROLS TO MINIMIZE DISRUPTION OF THE PHARMACEUTICAL SUPPLY CHAIN DURING THE COVID-19 PANDEMIC
Anthony M Cundell[SUP] 1 [/SUP], Dennis Edward Guilfoyle[SUP] 2 [/SUP], T R Kreil[SUP] 3 [/SUP], Anil Sawant[SUP] 4 [/SUP]
Affiliations
- PMID: 32467176
- DOI: 10.5731/pdajpst.2020.012021
Abstract
This article reviews currently available scientific literature related to the epidemiology, infectivity, survival, and susceptibility to disinfectants of Coronaviruses, in the context of the controls established to meet Good Manufacturing Practice regulations and guidance, and the public health guidance issued specifically to combat the Covid-19 pandemic. The possible impact of the COVID-19 pandemic on the pharmaceutical supply chain is assessed and recommendations are listed for risk mitigation steps to minimize supply disruption to pharmaceutical drug products. Areas addressed include a brief history of the COVID-19 viral pandemic, a description of the virus, the regulatory response to the pandemic, the screening of employees, the persistence on inanimate surfaces, cleaning and disinfection of manufacturing facilities, use of GMP-mandated personal protective equipment to counter the spread of the disease, the role of air changes in viral clearance, approaches to risk assessment and mitigation. Biological medicinal products have a great record of safety, yet the cell cultures used for production can be susceptible to viruses, and contamination events have occurred. Studies on SARS-CoV-1 for its ability to replicate in various mammalian cell lines used for biopharmaceutical manufacturing suggest SARS-CoV-2 poses low risk and any contamination would be detected by currently used adventitious virus testing. The consequences of the potential virus exposure of manufacturing processes, as well as the effectiveness of mitigation efforts are discussed. The pharmaceutical supply chain is complex, traversing many geographies and companies that range from large multinationals to mid and small size operations. This paper recommends practices that can be adopted by all companies, irrespective of their size, geographic location, or position in the supply chain.
Keywords: COVID-19 pandemic; SARS-CoV-2; drug shortage; risk assessment; risk mitigation; supply chain.