Microbial Contamination Risk Assessment in Non‐sterile Drug Product Manufacturing and Risk Mitigation

Author(s):  
Tony Cundell
2020 ◽  
Vol 115 ◽  
pp. 106424 ◽  
Author(s):  
Daniele la Cecilia ◽  
Giovanni M. Porta ◽  
Fiona H.M. Tang ◽  
Monica Riva ◽  
Federico Maggi

2016 ◽  
Vol 105 (11) ◽  
pp. 3243-3255 ◽  
Author(s):  
Paul A. Dickinson ◽  
Filippos Kesisoglou ◽  
Talia Flanagan ◽  
Marilyn N. Martinez ◽  
Hitesh B. Mistry ◽  
...  

2007 ◽  
Vol 70 (12) ◽  
pp. 2864-2867 ◽  
Author(s):  
LINDSAY ARTHUR ◽  
SANDRA JONES ◽  
MARTHA FABRI ◽  
JOSEPH ODUMERU

Recent produce-related outbreaks have been receiving heightened media coverage, which has increased public concern toward the safety of fresh fruits and vegetables. In response, the microbial contamination of Ontario-grown fresh fruits and vegetables was evaluated by the Ontario Ministry of Agriculture, Food and Rural Affairs during the summer of 2004. Prior to this survey, information specific to the microbial contamination of Ontario-produced fruits and vegetables was limited. This nonregulatory survey had two objectives: (i) to obtain a general microbiological profile of selected fruits and vegetables produced in Ontario and (ii) to use the information and knowledge gained from this survey to direct and support future on-farm food safety research and food safety programs to manage potential risks. In all, 1,183 samples, including muskmelon (151), scallions and green onions (173), leaf lettuce (263), organic leaf lettuce (112), head lettuce (155), parsley (127), cilantro (61), and fresh market tomatoes (141), were collected and analyzed. Samples were analyzed for Salmonella, Shigella, and generic E. coli. Enrichment cultures positive for E. coli were further assessed for verotoxigenicity. One sample each of Roma tomato and organic leaf lettuce were positive for Salmonella, with no samples yielding Shigella or verotoxigenic E. coli. The E. coli prevalence was highest in parsley (13.4%), followed by organic leaf lettuce (11.6%), leaf lettuce (6.5%), scallions (6.4%), cilantro (4.9%), muskmelon (1.3%), head lettuce (0%), and fresh market tomatoes (0%). These findings, in combination with foodborne illness data, will help target those commodities that require more focused risk mitigation efforts.


2013 ◽  
Vol 11 (01) ◽  
pp. 74-82
Author(s):  
Aachchhadita Sharma ◽  
Raju Mari Jeyaprakash ◽  
Raju Mari Jeyaprakash ◽  
Rinchi Bora ◽  
Abinash Chandra

Risk is intertwined with every drug product in a market. This article’s intent is to provide ground rule and praxis of different tools for Quality Risk Management (QRM) in various aspects of pharmaceutical science. QRM comprises of tools and processes which helps in establishing objectives. Hence they are also known as Enablers. Enablers help in risk mitigation of product quality throughout a lifecycle in such a way that benefit outweighs the risk. The key properties of Enablers or QRM, i.e., attempts made, solemnness and records shall be compatible with risk scale. The Enablers accomplishment gives recognized, obvious and steps of Enabler process produced by regeneratable methods which is based on customary comprehension to evaluate feasibility, ability to find out risk prejudice. The QRM or Enabler tools can assist the manufacturing company and regulatory bodies to scrutinize, handle, notify, and inspect the risk.


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