scholarly journals ANALISIS MANAJEMEN RISIKO PADA KANTOR PUSAT PT. BANK BENGKULU

2015 ◽  
Vol 2 (1) ◽  
Author(s):  
Dian Wundari Gustini ◽  
Sulisti Afriani
Keyword(s):  
Risk Assessment ◽  
Risk Management ◽  
Quantitative Analysis ◽  
Qualitative Analysis ◽  
Quality Risk Management ◽  
Average Value ◽  
Financial Position ◽  
Inherent Risk ◽  
Quality Risk

Dian Wundari Gustini, Sulisti Afriani; Analysis Of Risk Management in PT.Bank Bengkulu Office. This study aims to determine the Analysis Risk Management in PT . Bank Bengkulu Office. The type of is the study descriptive. In this study the samples used is the form of quality report application of risk management PT. Bank of Bengkulu in 2012. By the risk report can described the condition of PT. Bank Bengkulu and can be analyzed levels of application quality . For quantitative analysis using the inherent risk assessment , which is an assessment of the risks inherent Bank's business activities, both of which can be quantified or are not , and could potentially affect the financial position of the Bank. The qualitative analysis using indicators Quality Risk Management with the criteria and parameters that have been set by Bank Indonesia . This study showed an overview of the implementation of risk management at PT. Bank Bengkulu average value of 2.50 is in the interval from 1.81 to 2.60 with Satisfactory criteria is quality risk management of PT. Bank of Bengkulu in composite adequate , although there are minor flaws, but these flaws need to get the attention of the management of PT. Bank Bengkulu to make improvements. Assessment of the quality of risk management implementation in PT Bank Bengkulu can be traced from the stages of preparation of strategies, programs, policies, objectives, and implementation.

scholarly journals Quality Risk Management in Pharmaceutical Supply Chain, Warehousing and Dispensing -Practical Case Study from Sterile Pharmaceutical Industry

2021 ◽  
Vol 68 (2) ◽  
Author(s):  
Rawidh Alsaidalani ◽  
Bassam Elmadhoun
Keyword(s):  
Risk Assessment ◽  
Risk Management ◽  
Supply Chain ◽  
Quality Management System ◽  
Practical Case ◽  
Medicinal Products ◽  
Pharmaceutical Supply Chain ◽  
Quality Risk Management ◽  
Early Stages ◽  
Quality Risk

Quality Risk Management (QRM) during medicinal products manufacturing is now becoming an integral part of quality management system (QMS). Most if not all regulatory authorities have revised their current good manufacturing practices (GMP) to incorporate the concept of risk assessment in every single process regardless to the criticality of the process. Different Procedures in pharmaceutical QMS like deviation control, change control, investigation, customer complaints handling, validation & qualification, product release, etc. consider the principles of risk assessment at all steps. Extensive research in this area shows that there is scarcity of research on quality risk management during early stages of medicinal products manufacturing including (1) procurement/supply chain, (2) logistics/warehousing and (3) raw materials dispensing. To cover the gap in the literature, three practical case studies has been studied by selecting one major step from each manufacturing stage and applied risk assessment following the procedure described in ICHQ9 and using Failure Mode Effect Analysis (FMEA) as risk assessment quality tool. As a result of this review, QRM during early stages of medicinal products manufacturing may be useful to avoid unnecessary complaints or delay during subsequent drug processing in the manufacturing site. Being proactive and taking all necessary measures to avoid any possible defects or mishandling is one of the major objectives of QRM and ultimately patient protection. This study shows a model solution for industry professionals and regulators to reduce the possible risks associated with early stages of medicinal products manufacturing thereby paving the way for significant business growth.

scholarly journals PHARMACEUTICAL QUALITY MANAGEMENT SYSTEM: A REVIEW

2018 ◽  
Vol 2 (3) ◽  
pp. 67-78
Author(s):  
Shrey Sharma ◽  
R. B. Bodla ◽  
Shweta S. ◽  
D. P. Pathak
Keyword(s):  
Risk Management ◽  
Quality Control ◽  
Quality Management System ◽  
Drug Product ◽  
Quality Risk Management ◽  
Technical Requirements ◽  
Use Of Resources ◽  
Risk Management Process ◽  
Quality Risk

ICH is “International Conference on Harmonization” of technical requirements for registration of pharmaceuticals for human use. The goal of ICH is to discuss and establish common guidelines by bringing together three ICH regions i.e. USA, Japan and EU and to make information available on ICH, its activities and guidelines. The guidelines have become more relevant for Generic’s Drug Approval. Drug Development and manufactures are more and more global. Harmonization is considered more important than ever, as it facilitates work sharing, efficient use of resources and access to medicines. The objective of harmonization is meant for economical use of human, animal and other resources and the elimination of unnecessary delay in the global development and of availability of new medicines whilst maintaining safeguards on quality, safety and efficacy. The present discussion of the review is on ICH guidelines for quality control focussing mainly on Quality Risk Management (Q9). Quality control is a process that is used to ensure a certain level of quality in a product or service. It might include whatever action a business deems necessary to provide for the control and verification of certain characteristics of a product or service. Most often, it involves thoroughly examining and testing the quality of products or the results of services. The basic goal of this process is to ensure that the products or services that are provided meet specific requirements and characteristics, such as being dependable, satisfactory, safe and fiscally sound. Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug product across the product lifecycle. Two primary principles of quality risk management are: The evaluation of the risk to quality should be based on scientific knowledge and Ultimately linked to the protection of the patient; and The level of effort, formality, and documentation of the quality risk management process should be commensurate with the level of risk.

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.

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

Interactional metadiscourse of gender in Persian

2019 ◽  
Vol 10 (4) ◽  
pp. 512-537
Author(s):  
Mohammad Amouzadeh ◽  
Raha Zareifard
Keyword(s):  
Quantitative Analysis ◽  
Qualitative Analysis ◽  
Academic Status ◽  
Male And Female ◽  
Factors Influencing ◽  
Significant Difference ◽  
Conference Presentations

Abstract The present study sets out to investigate an important aspect of gendered performance, namely, the presence of interactional metadiscourse in conference presentations delivered in Persian. The study pursues two primary objectives: firstly, to compare the quantity and quality of interactional metadiscourse markers as expressed by male and female academics; secondly, to investigate some other factors influencing the phenomenon under investigation. The data include twenty-four conference presentations by twelve males and twelve females. The quantitative analysis showed a statistically significant difference in the use of interactional metadiscourse by male and female presenters. However, the qualitative analysis helped the authors to identify more similarities than differences. In point of fact, such factors as academic status and nativeness had caused the speakers to use different metadiscourse strategies.

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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