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.

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 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 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 End-to-end qualification of ready-to-use (RTU) product containers in packaging suitable for No-Touch Transfer (NTT) into Grade A filling zones

2021 ◽  
Author(s):  
Holger Kranenburg ◽  
Birte Scharf ◽  
Patrick Wolf ◽  
Robert Lindner
Keyword(s):  
Risk Management ◽  
Supply Chain ◽  
Good Manufacturing Practice ◽  
Study Data ◽  
Lower Grade ◽  
Quality Risk Management ◽  
Design Qualification ◽  
End To End ◽  
Quality Risk ◽  
High Level

No-Touch Transfer (NTT) of pre-sterilised ready-to-use (RTU) containers is an alternative methodology that follows Good Manufacturing Practice (GMP) and Quality Risk Management (QRM) principles. NTT de-bagging ejects contents from secondary bag packaging without direct contact with contents or exposure to an environment that is a lower grade than the zone being entered. The pre-sterilised containers and sterile barriers offer assured sterility at manufacture and are qualified to remain sterile through the supply chain and the stepwise NTT de-bagging process. This eliminates the requirement for in-process material disinfection steps for transfer into Grade A environments. The present article focuses on design qualification of pre-sterilised RTU container packaging, including definition of sterile barriers together with bioburden study data through the supply chain and simulated NTT. It completes a series of EJPPS articles to support peer-reviewed references on NTT. Together, these articles can be defined as end-to-end qualification of the NTT process, demonstrating a high level of assurance that sterility is maintained from manufacture to point of use. Key Words: Aseptic processing, Design qualification, Good Manufacturing Practice (GMP), Life cycle, No-Touch Transfer (NTT), Pharmaceutical packaging, Pre-sterilised containers, Qualification, Quality by Design (QbD), Quality Risk Management (QRM), Ready-to-use (RTU), Supply chain

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.

Nanomaterials in Medical Devices: Regulations' Review and Future Perspectives

2021 ◽  
pp. 1910-1917
Author(s):  
Karolina Jagiello ◽  
Anita Sosnowska ◽  
Alicja Mikolajczyk ◽  
Tomasz Puzyn
Keyword(s):  
Risk Assessment ◽  
Risk Management ◽  
Risk Analysis ◽  
Medical Devices ◽  
Future Perspectives ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Products ◽  
Probability Of Occurrence ◽  
Advanced Therapy ◽  
Related Harm

This article gives a brief description of the existing regulations related to biomaterials safety that need to be considered before it is introduced into EU market. According to these regulations, the risk analysis should include two characteristics: probability of occurrence of harm, and severity. Identified user-related harm should be reduced by managing the risk. Additionally, the review presents an overview of engineered biomaterials (EBMs), which in combination with nanoscale components (NPs) have shown promises in Advanced Therapy Medicinal Products (ATMP) and Medical Devices (MD). In this article, recent challenges, objectives and perspectives in risk assessment and risk management of ATMP and MD composed of nanobiomaterials were also highlighted.

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