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

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 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 Challenges of manufacturing site in batch certification and release in European Union

2019 ◽  
Vol 65 (2) ◽  
pp. 3-9
Author(s):  
Katerina Aleksievska Beldedovska ◽  
Jelena Acevska ◽  
Aneta Dimitrovska ◽  
Miroslava Ilievska
Keyword(s):  
Risk Management ◽  
Release Site ◽  
Good Manufacturing Practice ◽  
Quality System ◽  
Quality Risk Management ◽  
Pharmaceutical Quality ◽  
Batch Release ◽  
Risk Management Process ◽  
Pharmaceutical Quality System ◽  
Quality Risk

A comprehensively designed Pharmaceutical Quality System (PQS) incorporating Good Manufacturing Practice and Quality Risk Management implemented, maintained and continuously improved, allows a consistent delivery of products with appropriate quality attributes. The manufacturer in the third country and the batch certification and release site in EU belong to the same organization operating under a corporate Pharmaceutical Quality System. A signed Quality Agreement between both parties provides improvement of the Pharmaceutical Quality System and continual maintenance of the quality of the medicinal product throughout its shelf life. This paper outlines the role and the challenges of the manufacturing site in third country within the process of batch certification and release in EU (by EU QP) and also highlights the importance of the technically justified approach including Quality Risk Management process regarding sampling in third country. Through a Technical justification for sampling including Quality Risk Assessment, it is considered that the samples taken from the manufacturing site in third country ensure representation of the whole batch. Technical justification is performed periodically to identify and manage any risks associated with this approach, thus ensuring the quality, safety and efficacy according Marketing Authorization. Keywords: batch release in EU, third country, Pharmaceutical Quality System, QP

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.

A Multi-Agent-Based Research on Tourism Supply Chain Risk Management

2014 ◽  
Vol 13 (03) ◽  
pp. 133-153 ◽  
Author(s):  
Luo Biao ◽  
Wan Liang ◽  
Liang Liang
Keyword(s):  
Risk Management ◽  
Supply Chain ◽  
Tourism Industry ◽  
Limiting Factors ◽  
Supply Chain Risk Management ◽  
Agent Based ◽  
Research Perspective ◽  
Multi Agent ◽  
High Level ◽  
Tourism Supply Chain

The high level of complexity of tourism supply chain and the inherent risks that exist in the demand and supply of resources are viewed as major limiting factors in achieving high level performance. Though emerging literature on risk management in tourism industry or its equivalent exists, progress in this area is uneven, as most research focuses on this problem from the traditional single business risk management perspective, without considering the entire range of different suppliers involved in the provision and consumption of tourism products. This study applies risk management theory to a new research perspective, which is tourism supply chain management (SCM). This paper develops a framework for the design of a multi-agent-based decision support system (DSS) based on multi-agent theory and technique, in order to manage disruptions and mitigate risks in tourism supply chain.

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
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