The Application of Quality Risk Management to the Bacterial Endotoxins Test: Use of Hazard Analysis and Critical Control Points

2013 ◽  
Vol 67 (5) ◽  
pp. 553-567 ◽  
Author(s):  
C. Annalaura ◽  
D. Giulia ◽  
C. Stefano
Keyword(s):  
Risk Management ◽  
Hazard Analysis ◽  
Control Points ◽  
Quality Risk Management ◽  
Critical Control Points ◽  
Bacterial Endotoxins ◽  
Quality Risk ◽  
Test Use

scholarly journals Hazard Analysis and Critical Control Points as a Quality Risk Management Tool in the Pharmaceutical Industry: A Systematic Review

2021 ◽  
Vol 11 (5-S) ◽  
pp. 167-175
Author(s):  
, Priya ◽  
Meenu Chaudhary
Keyword(s):  
Risk Management ◽  
Hazard Analysis ◽  
Pharmaceutical Products ◽  
Management Tool ◽  
Control Points ◽  
Quality Risk Management ◽  
Drug Products ◽  
Critical Control Points ◽  
Pharmaceutical Industries ◽  
Quality Risk

For several years, quality risk management (QRM) has been such an integral component of healthcare as well as pharmaceutical product manufacturing. Effectual QRM can help companies make better informed and smarter choices, and furnish regulators with more prominent confirmation of an organization's capacity to manage possible dangers. In the pharmaceutical sector, the Hazard Analysis and Critical Control Points (HACCP), a QRM tool is comparatively a new approach. It is a globally perceived management system that gives rules to the pharmaceutical and food industries. HACCP approach emphasizes the hazards, with the overarching goal of ensuring that drug products are safe to use because the production of drug products is prone to health together with safety concerns. The HACCP system offers guidance to a considerable extent for quality control, by detecting, assessing, monitoring, and validating the crucial procedures and operations in the manufacturing of pharmaceutical products. The presented review article provides HACCP as a risk assessment tool, which could be applied to various parts of drug quality so that it might promote and assist the adoption of quality practices by pharmaceutical industries with the objective of improving HACCP efficiency together with company performance. Keywords:  HACCP, Hazards, QRM, Quality

scholarly journals The application of hazard analysis and critical control points and risk management in the preparation of anti-cancer drugs

2009 ◽  
Vol 21 (1) ◽  
pp. 44-50 ◽  
Author(s):  
B. Bonan ◽  
N. Martelli ◽  
M. Berhoune ◽  
M.-L. Maestroni ◽  
L. Havard ◽  
...  
Keyword(s):  
Risk Management ◽  
Hazard Analysis ◽  
Control Points ◽  
Cancer Drugs ◽  
Critical Control Points ◽  
Anti Cancer

HAZARD ANALYSIS CRITICAL CONTROL POINTS OF FARMYARD PRODUCTION OF WARA «¤?? A POPULAR NIGERIAN CATTLE MILK FOOD

2016 ◽  
Vol 15 (1) ◽  
pp. 69-82
Author(s):  
A. A.O. OGUNSHE ◽  
A. A. ADEOLA ◽  
V. O. ADETUNJI
Keyword(s):  
Hazard Analysis ◽  
Calotropis Procera ◽  
Control Points ◽  
Processing Conditions ◽  
Food Handlers ◽  
Preventive Control ◽  
Production Methods ◽  
Milk Samples ◽  
Fresh Milk ◽  
Critical Control Points

Hazard Analysis Critical Control Points of the production methods of farmyard-processed Nigerian wara were determined using survey studies and oral interviews. Low to moderate sources of microbial hazards included boiling of fresh cowmilk containing Calotropis procera extracts, transfering of moulded wara into boiled cowmilk whey, included addition of crushed Calotropis procera leaves and stem to fresh cowmilk and transporting wara to market for sale and packaging of wara for sale. High sources of microbial hazards were manual milking of several cows to obtain fresh milk samples, and collection of milk samples from different cows in same containers. Significant preventive control of the identified microbial hazards for wara were- keeping of cows in hygienic farmyards, non-milking of mas- titic / ill cows, proper hygiene by food handlers, usage of clean processing materials, wholesome wa- ter samples and hygienic processing conditions. There is need for effective HACCP for quality control and assurance of farmyard-produced Nigerian wara.

scholarly journals Application of Hazard Analysis of Critical Control Points (HACCP) Method to Describe Critical Points in Healthcare Waste Management of Razi Hospital in Ghaemshahr, Iran During COVID-19 Pandemic in 2020

2021 ◽  
Vol 13 (3) ◽  
Author(s):  
Seyedeh Fatemeh Erfaneh Mousavi ◽  
Fathollah Gholami-Borujeni
Keyword(s):  
Waste Management ◽  
Direct Contact ◽  
Hazard Analysis ◽  
Virus Transmission ◽  
Transmission Risk ◽  
Control Points ◽  
Healthcare Waste ◽  
Critical Control Points ◽  
Healthcare Waste Management ◽  
Corrective Actions

Background: During the outbreak of COVID-19 in developing countries such as Iran, the management of healthcare waste has become a very important issue. It is necessary to investigate the risk of virus transmission through direct contact, inhalation, and environmental pollution to reduce transmission risk. The Hazard Analysis of Critical Control Points framework is used to simplify quick responses of waste management for facing the novel infectious disease. Objectives: The aim of this study was to use risk analysis frameworks to describe hazard critical control points (HACCP) and make recommendations and corrective actions for staff who work in healthcare facilities and communities experiencing the COVID-19 outbreak. Methods: In the present descriptive-analytical study, a team of environmental health experts identified the critical control points of healthcare waste produced in Razi Hospital and divided them into three categories and six steps. A tested and verified hazard analysis flow diagram was prepared to determine critical points in different steps of healthcare waste management. Critical control points were identified and analyzed by the team at each step. Recommendations and corrective actions were made for each control point. Results: The production rate significantly increased from 580 to 1,733 kg per day, probably caused by the increased use of disposable waste during the pandemic. Transportation, disinfection, and storage appeared to be associated with an individually high level of transmission risk of COVID-19 virus. Also, direct contact with infectious waste was often associated with a high risk of virus transmission. In the final disposal of healthcare waste, people were exposed to a lower level of risk. Conclusions: Training staff in different wards of the hospital to use proper personal protective equipment (PPE), hand washing, disinfectants, and ventilation could reduce the risk of COVID-19 transmission through healthcare waste. Using the HACCP method for providing recommendations and corrective actions could simplify responses to reduce the transmission risk of COVID-19 during pandemics.

scholarly journals Impact of Quality Risk Management Process in Pharmaceutical Industry to Curtail the Non Conformity

2013 ◽  
Vol 11 (01) ◽  
pp. 74-82
Author(s):  
Aachchhadita Sharma ◽  
Raju Mari Jeyaprakash ◽  
Raju Mari Jeyaprakash ◽  
Rinchi Bora ◽  
Abinash Chandra
Keyword(s):  
Risk Management ◽  
Risk Mitigation ◽  
Drug Product ◽  
Management Process ◽  
Ground Rule ◽  
Quality Risk Management ◽  
Risk Management Process ◽  
Regulatory Bodies ◽  
Quality Risk ◽  
Risk Scale

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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