Quality Risk Management (QRM): Part II – Evaluating the Impact of Process Parameters on Critical Quality Attributes for Biopharmaceutical Products

2017 ◽  
Vol 15 (4) ◽  
pp. 22-31
Author(s):  
Mark Witcher ◽  
Keyword(s):  
Risk Management ◽  
Process Parameters ◽  
Quality Attributes ◽  
Critical Quality Attributes ◽  
Quality Risk Management ◽  
Quality Risk ◽  
The Impact

Modeling enablers of supply chain quality risk management: a grey-DEMATEL approach

2019 ◽  
Vol 32 (5) ◽  
pp. 1059-1076
Author(s):  
Anupama Prashar ◽  
Shikha Aggarwal
Keyword(s):  
Risk Management ◽  
Supply Chain ◽  
Empirical Study ◽  
Early Stage ◽  
Content Type ◽  
Quality Risk Management ◽  
Automotive Supply Chain ◽  
Quality Risk ◽  
Automotive Supply ◽  
The Impact

Purpose The purpose of this paper is to recognize and model the enablers of supply chain quality risk management (SCQRM) through an empirical study in the Indian automotive companies. Design/methodology/approach A systematic literature review was conducted to extract the key enablers of quality management (QM) and risk management in the context of manufacturing supply chains. A grey-based DEMATEL method was employed to identify and model the key enablers of SCQRM. Findings The results of empirical study showed that the effectiveness of QM and risk management systems for automotive supply chain is driven by a set of common enablers that could be employed for developing dedicated SCQRM systems. The common causal factors in the model such as the involvement of top leaders, inter-firm communication and strategic-level alignment between supply chain members on both these issues clearly state that there is a need for a broader policy at an early stage. Practical implications It is crucial for the automotive companies to develop and implement structured systems for SCQRM keeping in view the impact of any unaddressed quality risk on missed production targets, vehicle recalls and safety hazards. Originality/value This study ascertains the key enablers of SCQRM with emblematic focus on automotive industry and identifies if there are commonalities in these enablers.

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.

scholarly journals Design Space Approach in Optimization of Fluid Bed Granulation and Tablets Compression Process

2012 ◽  
Vol 2012 ◽  
pp. 1-10 ◽  
Author(s):  
Jelena Djuriš ◽  
Djordje Medarević ◽  
Marko Krstić ◽  
Ivana Vasiljević ◽  
Ivana Mašić ◽  
...  
Keyword(s):  
Process Parameters ◽  
Design Space ◽  
Quality Attributes ◽  
Dissolution Profile ◽  
Compression Force ◽  
Critical Quality Attributes ◽  
Fluid Bed ◽  
Fluid Bed Granulation ◽  
Atomization Pressure ◽  
Space Approach

The aim of this study was to optimize fluid bed granulation and tablets compression processes using design space approach. Type of diluent, binder concentration, temperature during mixing, granulation and drying, spray rate, and atomization pressure were recognized as critical formulation and process parameters. They were varied in the first set of experiments in order to estimate their influences on critical quality attributes, that is, granules characteristics (size distribution, flowability, bulk density, tapped density, Carr's index, Hausner's ratio, and moisture content) using Plackett-Burman experimental design. Type of diluent and atomization pressure were selected as the most important parameters. In the second set of experiments, design space for process parameters (atomization pressure and compression force) and its influence on tablets characteristics was developed. Percent of paracetamol released and tablets hardness were determined as critical quality attributes. Artificial neural networks (ANNs) were applied in order to determine design space. ANNs models showed that atomization pressure influences mostly on the dissolution profile, whereas compression force affects mainly the tablets hardness. Based on the obtained ANNs models, it is possible to predict tablet hardness and paracetamol release profile for any combination of analyzed factors.

ICH Q9 Quality Risk Management

2017 ◽  
pp. 579-610 ◽  
Author(s):  
David Elder ◽  
Andrew Teasdale
Keyword(s):  
Risk Management ◽  
Quality Risk Management ◽  
Quality Risk

Quality Risk Management

2015 ◽  
pp. 423-434
Author(s):  
Yvonne Bouwman-Boer ◽  
Lilli Møller Andersen
Keyword(s):  
Risk Management ◽  
Quality Risk Management ◽  
Quality Risk

Identifying and assessing highly hazardous drugs within quality risk management programs

2016 ◽  
Vol 79 ◽  
pp. S11-S18 ◽  
Author(s):  
Robert G. Sussman ◽  
Anthony R. Schatz ◽  
Tracy A. Kimmel ◽  
Allan Ader ◽  
Bruce D. Naumann ◽  
...  
Keyword(s):  
Risk Management ◽  
Quality Risk Management ◽  
Quality Risk ◽  
Hazardous Drugs

Quality Risk Management-Based AQbD Approach to Development of VEER Chromatography Method for the Estimation of Multiple Combined Formulations of Anti-Hypertensive Drugs

2020 ◽  
Author(s):  
Pintu B Prajapati ◽  
Mukti A Thakor ◽  
Kunjan B Bodiwala ◽  
Shailesh A Shah
Keyword(s):  
Risk Management ◽  
Dosage Forms ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Forms ◽  
Quality Risk Management ◽  
Screening Design ◽  
Quality Risk ◽  
Quality By Design Approach ◽  
Risk Parameters

Abstract Background A number of chromatography methods for estimating combined dosage forms of telmisartan have been published in the literature, but each combined dosage form needs separate chromatography conditions for analysis. Objective The versatile, economical, eco-friendly, and robust chromatographic method has been developed for simultaneous estimation of multiple combined pharmaceutical dosage forms of anti-hypertensive drugs using the analytical quality by design approach based on principles of quality risk management (QRM) and design of experiment (DoE). Method Analytical QRM was performed by identifying probable method risk parameters and risk assessment for the development of the method. DoE was performed by Taguchi Orthogonal Array (OA)  screening design and Box-Behnken response surface design using Design-Expert software (trial version). Chromatographic separation was performed using silica gel 60 GF254 as stationary phase and toluene:ethyl acetate:methanol:glacial acetic acid (5.5 + 2 + 1 + 0.2, v/v/v/v) as a mobile phase keeping saturation time of 15 min. The developed method was applied for the assay of six combined pharmaceutical dosage forms of anti-hypertensive drugs. Results The developed method was found to be validated for accuracy, precision, specificity, linearity, LOD, LOQ, and robustness as per ICH guideline. The results of the assay were found in good agreement with the labelled claim. Conclusions The developed method can be applied for analysis and quality control of multiple combined dosage forms of telmisartan. Highlights A QRM and DoE-based AQbD approach was applied for development of chromatography method for simultaneous estimation of multiple combined dosage forms of telmisartan. The developed method was successfully applied for simultaneous estimation of six different multiple combined dosage forms of temisrtan.

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