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

Application of Quality Risk Assessment and DoE-Based Enhanced Analytical Quality by Design Approach to Development of Chromatography Method for Estimation of Combined Pharmaceutical Dosage Form of Five Drugs

2020 ◽  
Author(s):  
Pintu B Prajapati ◽  
Kajal Jayswal ◽  
Shailesh A Shah
Keyword(s):  
Risk Management ◽  
High Performance ◽  
Quality By Design ◽  
Simultaneous Estimation ◽  
Analytical Quality ◽  
Chromatography Method ◽  
Quality Risk Management ◽  
Pharmaceutical Industries ◽  
Quality Risk ◽  
Hptlc Method

Abstract The high-performance liquid chromatography method was only reported for simultaneous estimation of aspirin, simvastatin, ramipril, atenolol and hydrochlorothiazide in polycap capsule. High-performance thin-layer chromatography (HPTLC) method is now accepted as a method of analysis by many pharmaceutical industries and included as an official method in monographs of pharmacopeias of many countries. Hence, HPTLC method was developed and validated for the estimation of polycap capsule using enhanced analytical quality by design based on principles of quality risk management and design of experiment (DOE). Quality risk management was performed by the identification and assessment of risky method parameters. DoE was carried out by Placket–Burman screening design and Box–Behnken response surface methodology using resolution and tailing factor as critical method attributes. Method operable design region was navigated for optimization and development of the method. The developed method was validated as per ICH Q2 (R1) guideline. The method was found accurate, specific, precise and sensitive for the said estimation. The developed method was applied for the assay of polycap capsule and results were found in good agreement with the labeled claim. The developed method can be used as an alternative to reported HPLC methods for quality control of polycap capsule.

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.

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