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.

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 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 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

Research of Innovative Risk Management in L/C Settlement - Based on Quality Control of Import Goods

2014 ◽  
Vol 472 ◽  
pp. 1037-1041
Author(s):  
Hao Zhou
Keyword(s):  
Risk Management ◽  
Quality Control ◽  
International Trade ◽  
Letter Of Credit ◽  
Fraud Risk ◽  
Soft Term ◽  
Quality Risk

Quality of import goods is possibly not up to standard in letter of credit settlement. In order to control the quality of import goods and to prevent exporter from fraudulent credit, importer takes some of the most effective terms that will be considered as soft term fraud by exporter. This paper analyzed the reason for the existence of such risks, and proposed innovative ideas on how to effectively control the quality of import goods in letter of credit settlement. Letter of credit (hereinafter referred as L/C) settlement serves as a more effective, timely and safe transaction way for both sellers and buyer in international trade, but there is still the risk of fraud [. Fraud risk is the greatest one in letter of credit settlement. Buyers will attach great importance to the quality of import goods, but exporter fraud will lead import goods not up to standard. In order to prevent such a quality risk, the importer will set some terms in the L/C, but these terms may be considered as soft term fraud by exporter. Research of risk management in L/C settlement will help importer effectively control the quality of import goods, and promote the L/C settlement.

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