scholarly journals THE MANAGEMENT OF PROCESS LEAD TIME IN THE RELEASE OF STERILE PHARMACEUTICAL BATCHES: A CASE STUDY OF OPTIMIZATION IN AN OFFICIAL BRAZILIAN PHARMACEUTICAL LABORATORY

2021 ◽  
Vol 16 (1) ◽  
pp. 42-51
Author(s):  
Maria Tereza de Sousa Silva ◽  
Edison Nunes da Silva Junior ◽  
Jorge Magalhães ◽  
Vanessa da Silveira dos Santos Pacheco
Keyword(s):  
Risk Management ◽  
Failure Modes ◽  
Pharmaceutical Product ◽  
Release Time ◽  
Risk Level ◽  
Management Tools ◽  
Release Process ◽  
Quality Program ◽  
Batch Release ◽  
Fmea Method

Medicines must comply with quality, safety, and efficacy pillars. Nowadays, organizations seek to incorporate new management models encouraged by quality program following the world trend regarding the technological revolution. The present research aims to improve the sterile pharmaceutical product batches release process, using the Failure Mode Effects Analysis (FMEA) method. This study addresses the gap in literature on quality risk management during batch release. The methodology uses a form adapted to the process in order to systematize the information, improving its comparison and analysis, thus estimating, the identification of potential failure modes and their effects on their performance. Made it possible to assign values for the severity, occurrence, and failure modes detection, to then determine the risk level and the priority of risk level. The results obtained showed the mitigation and elimination of failures in the process, as well as opportunities for improvement and causes of failures identification, improvement in the process performance indicators, greater reliability, and reduction in batch release time. Keywords: good manufacturing practices pharmaceutical industry, risk management, risk management tools

Continual improvement of the pre-analytical process in a public health laboratory with quality indicators-based risk management

2019 ◽  
Vol 57 (10) ◽  
pp. 1530-1538 ◽  
Author(s):  
Canan Karadağ ◽  
Nafi Nevrez Demirel
Keyword(s):  
Public Health ◽  
Risk Management ◽  
Quality Indicators ◽  
Failure Modes ◽  
Public Health Laboratory ◽  
Risk Level ◽  
Continual Improvement ◽  
Risk Levels ◽  
Analytical Process ◽  
Risk Treatment

Abstract Background Quality indicators (QIs) and risk management are important tools for a quality management system designed to reduce errors in a laboratory. This study aimed to show the effectiveness of QI-based risk management for the continual improvement of pre-analytical processes in the Kayseri Public Health Laboratory (KPHL) which serves family physicians and collects samples from peripheral sampling units. Methods QIs of pre-analytical process were used for risk assessment with the failure modes and effects analysis (FMEA) method. Percentages and risk priority numbers (RPNs) of QIs were quantified. QI percentages were compared to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) performance specifications and RPNs were compared to risk level scale, and corrective actions planned if needed. The effectiveness of risk treatment actions was re-evaluated with the new percentages and with RPNs of predefined QIs. Results RPNs related to four QIs required corrective action according to the risk evaluation scale. After risk treatment, the continual improvement was achieved for performance and risk level of “transcription errors”, for risk levels of “misidentified samples” and “not properly stored samples” and for the performance of “hemolyzed samples”. “Not properly stored samples” had the highest risk score because of sample storage and centrifugation problems of peripheral sampling units which are not under the responsibility of the KPHL. Conclusions Public health laboratories may have different risk priorities for pre-analytical process. Risk management based on predefined QIs can decrease the risk levels and increase QI performance as evidence-based examples for continual improvement of the pre-analytical process.

scholarly journals Assessment and Risk Management of Potential Hazards by Failure Modes and Effect Analysis (FMEA) Method in Yazd Steel Complex

2014 ◽  
Vol 04 (03) ◽  
pp. 127-135 ◽  
Author(s):  
Mehrzad Ebrahemzadih ◽  
G. H. Halvani ◽  
Behzad Shahmoradi ◽  
Omid Giahi
Keyword(s):  
Risk Management ◽  
Failure Modes ◽  
Effect Analysis ◽  
Fmea Method

scholarly journals Compliance with Good Manufacturing Practice in the Assessment of Immunomodulation Potential of Clinical Grade Multipotent Mesenchymal Stromal Cells Derived from Wharton’s Jelly

Cells ◽  
2019 ◽  
Vol 8 (5) ◽  
pp. 484 ◽  
Author(s):  
Marta Grau-Vorster ◽  
Luciano Rodríguez ◽  
Anna del Mazo-Barbara ◽  
Clémentine Mirabel ◽  
Margarita Blanco ◽  
...  
Keyword(s):  
Risk Management ◽  
Failure Modes ◽  
High Capacity ◽  
Wharton’S Jelly ◽  
Clinical Grade ◽  
Multipotent Mesenchymal Stromal Cell ◽  
Bioprocess Design ◽  
Wharton's Jelly ◽  
Batch Release ◽  
Potential Impact

Background: The selection of assays suitable for testing the potency of clinical grade multipotent mesenchymal stromal cell (MSC)-based products and its interpretation is a challenge for both developers and regulators. Here, we present a bioprocess design for the production of Wharton’s jelly (WJ)-derived MSCs and a validated immunopotency assay approved by the competent regulatory authority for batch release together with the study of failure modes in the bioprocess with potential impact on critical quality attributes (CQA) of the final product. Methods: The lymphocyte proliferation assay was used for determining the immunopotency of WJ-MSCs and validated under good manufacturing practices (GMP). Moreover, failure mode effects analysis (FMEA) was used to identify and quantify the potential impact of different unexpected situations on the CQA. Results: A production process based on a two-tiered cell banking strategy resulted in batches with sufficient numbers of cells for clinical use in compliance with approved specifications including MSC identity (expressing CD73, CD90, CD105, but not CD31, CD45, or HLA-DR). Remarkably, all batches showed high capacity to inhibit the proliferation of activated lymphocytes. Moreover, implementation of risk management tools led to an in-depth understanding of the manufacturing process as well as the identification of weak points to be reinforced. Conclusions: The bioprocess design showed here together with detailed risk management and the use of a robust method for immunomodulation potency testing allowed for the robust production of clinical-grade WJ-MSCs under pharmaceutical standards.

scholarly journals Model of evaluation of enterprise risk management

2019 ◽  
pp. 55-63
Author(s):  
Jonas Mackevičius ◽  
Lukas Giriūnas
Keyword(s):  
Risk Management ◽  
Risk Identification ◽  
Enterprise Risk Management ◽  
Risk Classification ◽  
Risk Level ◽  
Management Tools ◽  
Enterprise Risk ◽  
Evaluation Problem ◽  
Risk Determinants ◽  
Enterprise Activity

It should be noted that in this article the enterprise‘s activity risk management and evaluation problem is defined. The risk classification is defined in these criteries: coming way, effect, activity‘s area, time, probability of result, probability of management, importance and misuses. The model of evaluation of enterprise risk management is recommended. The model consists of these stages of risk management and evaluation: 1) identification of enterprise activity internals, 2) identification of risk determinants, 3) risk identification, 4) evaluation of risk level, 5) evaluation of risk consequence, 6) system of risk management tools, 7) evaluation of costs of risk management, 8) choice of strategy of risk management, 9) evaluation of results.

Design Thinking as a Tool for the Analysis of Project Risks

2019 ◽  
Vol 16 (6) ◽  
pp. 60-77
Author(s):  
E. V. Vasilieva ◽  
T. V. Gaibova
Keyword(s):  
Risk Management ◽  
Risk Analysis ◽  
Design Thinking ◽  
Management Tools ◽  
Project Risk ◽  
Team Members ◽  
Investment Projects ◽  
Risk Management Process ◽  
Project Objectives ◽  
Project Risk Analysis

This paper describes the method of project risk analysis based on design thinking and explores the possibility of its application for industrial investment projects. Traditional and suggested approaches to project risk management have been compared. Several risk analysis artifacts have been added to the standard list of artifacts. An iterative procedure for the formation of risk analysis artifacts has been developed, with the purpose of integrating the risk management process into strategic and prompt decision-making during project management. A list of tools at each stage of design thinking for risk management within the framework of real investment projects has been proposed. The suggested technology helps to determine project objectives and content and adapt them in regards to possible; as well as to implement measures aimed at reducing these risks, to increase productivity of the existing risk assessment and risk management tools, to organize effective cooperation between project team members, and to promote accumulation of knowledge about the project during its development and implementation.The authors declare no conflict of interest.

The prospects of occupational risk management during reforms of regulatory legislation basis

2019 ◽  
pp. 39-44 ◽  
Author(s):  
Vadim B. Alekseev ◽  
Nina V. Zaitseva ◽  
Pavel Z. Shur
Keyword(s):  
Risk Assessment ◽  
Risk Management ◽  
Social Insurance ◽  
Well Being ◽  
Occupational Risk ◽  
Risk Level ◽  
Federal Law ◽  
Work Safety ◽  
Risk Levels ◽  
Legal Principles

Despite wide legislation basis of regulating relations in work safety and workers’ health, one third of workplaces demonstrate exceeded allowable normal levels of workers’ exposure to occupational hazards and present occupational risk for health disorders.In accordance to national legislation acts, evaluation should cover factors of occupational environment and working process, and occupational risk is understood in context of mandatory social insurance. This approach has been formed due to mostly compensatory trend in legal principles of work safety in Russia by now. Implementation of new preventive concept of work safety, based on idea of risk management for workers, necessitates development of legal acts that regulate requirements to evaluation of occupational risk and its reports with consideration of changes in Federal Law on 30 March 1999 №52 FZ “On sanitary epidemiologic well-being of population”.Those acts can include Sanitary Rules and Regulations “Evaluation of occupational risk for workers’ health”, that will contain main principles of risk assessment, requirements to risk assessment, including its characteristics which can serve as a basis of categorizing the risk levels with acceptability.To standardize requirements for informing a worker on the occupational risk, the expediency is specification of sanitary rules “Notifying a worker on occupational risk”. These rules should contain requirements: to a source of data on occupational risk level at workplace, to informational content and to ways of notifying the worker. Specification and implementation of the stated documents enable to fulfil legal requirements completely on work safety — that will provide preservation and increase of efficiency in using work resources.

The Risk-Based Approach to Data Protection

2020 ◽  
Author(s):  
Raphaël Gellert
Keyword(s):  
Risk Management ◽  
Data Protection ◽  
Personal Data ◽  
Management Tools ◽  
General Data Protection Regulation ◽  
Regulation Theory ◽  
Régulation Theory ◽  
General Data ◽  
Data Protection Law ◽  
The Way

The main goal of this book is to provide an understanding of what is commonly referred to as “the risk-based approach to data protection”. An expression that came to the fore during the overhaul process of the EU’s General Data Protection Regulation (GDPR)—even though it can also be found in other statutes under different acceptations. At its core it consists in endowing the regulated organisation that process personal data with increased responsibility for complying with data protection mandates. Such increased compliance duties are performed through risk management tools. It addresses this topic from various perspectives. In framing the risk-based approach as the latest model of a series of regulation models, the book provides an analysis of data protection law from the perspective of regulation theory as well as risk and risk management literatures, and their mutual interlinkages. Further, it provides an overview of the policy developments that led to the adoption of such an approach, which it discusses in the light of regulation theory. It also includes various discussions pertaining to the risk-based approach’s scope and meaning, to the way it has been uptaken in statutes including key provisions such as accountability and data protection impact assessments, or to its potential and limitations. Finally, it analyses how the risk-based approach can be implemented in practice by providing technical analyses of various data protection risk management methodologies.

Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

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