THE MANAGEMENT OF PROCESS LEAD TIME IN THE RELEASE OF STERILE PHARMACEUTICAL BATCHES: A CASE STUDY OF OPTIMIZATION IN AN OFFICIAL BRAZILIAN PHARMACEUTICAL LABORATORY | Problems of Management in the 21st Century

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

Title	THE MANAGEMENT OF PROCESS LEAD TIME IN THE RELEASE OF STERILE PHARMACEUTICAL BATCHES: A CASE STUDY OF OPTIMIZATION IN AN OFFICIAL BRAZILIAN PHARMACEUTICAL LABORATORY
Publication Type	Journal Article
Year of Publication	2021
Authors	de Silva, MTS, da Junior, ENS, Magalhães, J, da dos Pacheco, VSS
Journal	Problems of Management in the 21st Century
Volume	16
Issue	1
Start Page	42-51
Pagination	Continuous
Date Published	June/2021
Type of Article	Original article
ISSN	2029-6932
Other Numbers	E-ISSN 2538-712X
Keywords	good manufacturing practices pharmaceutical industry, risk management, risk management tools
Abstract	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.
URL	http://oaji.net/articles/2021/450-1624470982.pdf
DOI	10.33225/pmc/21.16.42
Refereed Designation	Refereed
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