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Articles de revues sur le sujet « Quality Risk Management (QRM) »

Auteur : Grafiati

Publié le 2 juin 2025

Mis à jour le 31 juillet 2025

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1

Pathodiya, Manish. "Quality Risk Management: Degree of formality, Formal and Informal QRM." Journal of Drug Delivery and Therapeutics 15, no. 2 (2025): 124–28. https://doi.org/10.22270/jddt.v15i2.6978.

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The International Council for Harmonization’s (ICH) Q9 (R1): Quality Risk Management (QRM) guideline made effective from May, 2023. ICH Q9’s revision provides guidance on QRM for the pharmaceutical industry and regulatory environment. It aims to improve decision-making by offering a systematic approach that complements existing quality practices and guidelines. The document emphasizes that understanding formality in quality risk management can optimize resource usage and support risk-based decision-making by reflecting the level of importance, uncertainty, and complexity of the decision.5 QRM

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Priya, Wagh* Ramdas Darade. "Quality Risk Management in Pharmaceutical Industry: A Review." International Journal of Scientific Research and Technology 2, no. 3 (2025): 528–33. https://doi.org/10.5281/zenodo.15091362.

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This piece intends to outline the foundational principles and practical examples of Quality Risk Management (QRM) tools applicable across various facets of pharmaceutical quality assurance. These facets encompass development, production, distribution, inspection, and the submission of review processes throughout the drug substance, product, and biological product lifecycles. Quality Risk Management represents a comprehensive and ongoing endeavour to reduce risks to product quality throughout its lifecycle, aiming to maximize its benefits while maintaining a risk benefit balance. It is a struct

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Sharma, Aachchhadita, Raju Mari Jeyaprakash, Raju Mari Jeyaprakash, Rinchi Bora, and Abinash Chandra. "Impact of Quality Risk Management Process in Pharmaceutical Industry to Curtail the Non Conformity." International Journal of Pharmaceutical Quality Assurance 11, no. 01 (2013): 74–82. http://dx.doi.org/10.25258/ijpqa.11.1.28.

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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

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Sucipto, S. Wulandari, and I. Ariani. "Quality risk analysis of cocoa agroindustry: a case study in Pesawaran District, Lampung Province." IOP Conference Series: Earth and Environmental Science 892, no. 1 (2021): 012058. http://dx.doi.org/10.1088/1755-1315/892/1/012058.

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Abstract Quality is a critical issue in small and medium scale cocoa agroindustry, which affected competitiveness significantly. Product quality is strongly influenced by implementing best practices in cocoa production and processing. This study aims to identify quality risks, analyze risks, and develop risk management strategies in the cocoa agroindustry using a case study. Analysis used Quality Risk Matrix to map the risks and Analytical hierarchy process to develop a quality risk management (QRM). The results showed that blooming is the highest quality risk, followed by taste differences, m

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Sumukha Krishna P, Gangadharappa H V, Nagendra S, and Hemanth Kumar S. "An Overview of Risk Management and Risk-based Cleaning Validation." International Journal of Research in Pharmaceutical Sciences 11, no. 4 (2020): 5407–14. http://dx.doi.org/10.26452/ijrps.v11i4.3168.

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Risk in general means exposure to harm or a factor that can contribute towards bringing harm to a system. Almost every operation in the pharmaceutical industry is susceptible to risks. There is a need to overcome risks and them to prevent unwanted changes in product quality and safety. This prevention can be done by carrying out quality risk management (QRM) that facilitates the proper of risks, risk analysis, risk assessment to control and reduce risks. ICH Q9 guidelines explain quality risk management and its applications in the pharmaceutical industry. Cleaning validation is performed to ve

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Tishkov, S. V., E. V. Blynskaya, K. V. Alekseev, and V. K. Alekseev. "Features of risk analysis, assessment and control methods in pharmaceutical development." Russian Journal of Biotherapy 22, no. 1 (2023): 28–41. http://dx.doi.org/10.17650/1726-9784-2023-22-1-28-41.

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Quality Risk Management (QRM) is an important aspect of pharmaceutical development in the Quality-by-Design paradigm, since it determines the Design Space, critical quality attributes and critical process attributes.The purpose of this review is to systematize and analyze the main aspects of the QRM system in relation to each element of pharmaceutical development. This review article discusses the following key elements of QRM such as: risk analysis, risk control, risk communication, risk verification. For risk analysis, the advantages and disadvantages of QRM tools such as Preliminary Hazard

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Priya, ,., and Meenu Chaudhary. "Hazard Analysis and Critical Control Points as a Quality Risk Management Tool in the Pharmaceutical Industry: A Systematic Review." Journal of Drug Delivery and Therapeutics 11, no. 5-S (2021): 167–75. http://dx.doi.org/10.22270/jddt.v11i5-s.5094.

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For several years, quality risk management (QRM) has been such an integral component of healthcare as well as pharmaceutical product manufacturing. Effectual QRM can help companies make better informed and smarter choices, and furnish regulators with more prominent confirmation of an organization's capacity to manage possible dangers. In the pharmaceutical sector, the Hazard Analysis and Critical Control Points (HACCP), a QRM tool is comparatively a new approach. It is a globally perceived management system that gives rules to the pharmaceutical and food industries. HACCP approach emphasizes t

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Nauman, Dr Muhammad, and Rehana Bano. "Implementation of Quality Risk Management (QRM) In Pharmaceutical Manufacturing Industry." IOSR Journal of Pharmacy and Biological Sciences 9, no. 1 (2014): 95–101. http://dx.doi.org/10.9790/3008-091495101.

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Witcher, Mark. "Quality Risk Management (QRM): Identifying, Evaluating, and Mitigating Threat Risks to Biopharmaceutical Enterprises." BioProcessing Journal 15, no. 3 (2016): 21–29. http://dx.doi.org/10.12665/j153.witcher.

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Haddad, Ghada, and Anne Greene. "Quality Risk Management Competency Model—Case for the Need for QRM Competencies." PDA Journal of Pharmaceutical Science and Technology 73, no. 4 (2019): 331–44. http://dx.doi.org/10.5731/pdajpst.2019.009944.

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Sayantani Dey, Sayantani Dey, and Tapan Kumar Chaudhuri Tapan Kumar Chaudhuri. "Hazard Operability Analysis (Hazop): A Quality Risk Management Tool for the Protection of Quality Drugs." International Journal of Pharmaceutical Research and Applications 10, no. 2 (2025): 2091–97. https://doi.org/10.35629/4494-100220912097.

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Hazard and operability study is a systematic and structured technique which is used to identify the potential hazards and evaluate the problems associated with systems. The health ministry's largest-ever survey to assess drug quality revealed that more than 10% of medications in the government supply chain were "Not of Standard Quality" (NSQ). Comparatively, samples collected from retail locations nationwide showed an estimated 3% of NSQ medications, whereas 0.023% of the samples were determined to be fake.According to the survey, the combined prevalence of NSQ and fake medications nationwide

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Chen, Shan, Xiaoguang Liang, Mingmao Li, and Chuanlong Zou. "Research on Quality Risk Assessment and Application of Large-scale Clusters of Engineering Project." E3S Web of Conferences 233 (2021): 03058. http://dx.doi.org/10.1051/e3sconf/202123303058.

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In order to study the quality risk of large-scale clusters of engineering project and makes the characteristic analysis of large-scale clusters of engineering project and evaluates quality risk, the author uses analytic hierarchy process to quantify quality risk factor, and the following conclusions are obtained: (a) Construction management unit that makes the project decision-making mainly controls the QRM, comparatively speaking, it has little control over quality risk when the project is completed and ready to get acceptance (b) In the project decision-making stage, the Construction Technol

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Witcher, Mark. "Quality Risk Management (QRM): Part III – An Approach for Understanding and Either Accepting or Mitigating the Results of a QRM Analysis." BioProcessing Journal 16, no. 1 (2017): 25–31. http://dx.doi.org/10.12665/j161.witcher.q.

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Alsaidalani, Rawidh, and Bassam Elmadhoun. "Quality Risk Management in Pharmaceutical Manufacturing Operations: Case Study for Sterile Product Filling and Final Product Handling Stage." Sustainability 14, no. 15 (2022): 9618. http://dx.doi.org/10.3390/su14159618.

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In the highly regulated pharmaceutical industry, significant risks to products/processes must be formally identified, reduced, and controlled to minimize potential negative impacts on patients. Failure Modes and Effects Analysis (FMEA) is one of the well-recognized risk-management tools which is effectively used by the pharmaceutical industry to document and communicate risk control. International Conference on Harmonization (ICH) guideline Q9, Quality Risk Management (QRM), represents the first internationally recognized guideline specifically addressing QRM for the pharmaceutical and biophar

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Marodiyah, Inggit, and Indung Sudarso. "ANALISIS PENINGKATAN KUALITAS PROSES PEMBANGUNAN GEDUNG 7 DENGAN PENDEKATAN QUALITY RISK MANAGEMENT (QRM) DAN FAILURE MODE EFFECTS AND CRITICALITY ANALYSIS (FMECA)." Tekmapro : Journal of Industrial Engineering and Management 15, no. 2 (2020): 49–60. http://dx.doi.org/10.33005/tekmapro.v15i2.164.

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Manajemen kualitas digunakan untuk mengevaluasi kualitas bangunan, sedangkan manajemen risiko digunakan untuk mengetahui risiko yang berpengaruh terhadap kualitas bangunan. Seperti sumber daya manusia yang tidak memakai alat pelindung diri (APD) saat melakukan pekerjaan dikarenakan dengan alasan pekerjaan semakin lama serta ribet dikerjakan. Sehingga dengan adanya beberapa proses yang belum terstandar, maka dapat berisiko mempengaruhi kualitas pembangunan yang tidak sesuai harapan. Tujuan dilakukan penelitian ini adalah untuk mengetahui tingkat risiko yang berpengaruh terhadap kualitas pembang

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Anggriawan, Anggriawan, and Novera Elisa Triana. "Perbaikan Kualitas Semen Portland Komposit Melalui Penggantian Gipsum Sintetis dengan Metode Quality Risk Management (Qrm)." Jurnal Inovasi Global 3, no. 1 (2025): 2292–310. https://doi.org/10.58344/jig.v3i1.262.

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Penelitian ini bertujuan untuk menganalisis dampak subtitusi material aditif gipsum sintetis terhadap kualitas produk dan biaya produksi Semen Portland komposit di Industri Semen. Dengan meningkatnya persaingan dalam industri semen, perusahaan dituntut untuk menghasilkan produk berkualitas tinggi dengan biaya yang efisien. Subtitusi gipsum sintetis yang dilakukan bertujuan untuk meningkatkan kualitas semen, mengingat kandungan fosfor penta oksida (P2O5) yang tinggi pada gipsum sintetis lama dapat menyebabkan waktu pengikatan yang lebih lama dan potensi kegagalan produk. Metode yang digunakan d

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Pathodiya, Manish. "Cross-contamination Risk Assessment using FMEA tool." Journal of Drug Delivery and Therapeutics 14, no. 9 (2024): 164–67. http://dx.doi.org/10.22270/jddt.v14i9.6765.

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In pharmaceutical manufacturing facilities, products with different therapeutic properties and potencies are manufactured in shared spaces, which poses a potential risk for cross-contamination. During the manufacturing process, cross-contamination may occur due to the uncontrolled release of dust, gases/vapors, mix-ups with other materials, residues on equipment, and contamination from operator’s clothing. By implementing adequate facility design and manufacturing operations aligned with Quality Risk Management principles, the risk of cross-contamination can be controlled. If a shared facility

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Patil, Swapnil Bapu, Gaurav Jain, Jeevan Patel, Ramakant Sharma, Shabnam Khan, and Rakesh Patel. "A QbD Approach on Pharmaceutical Development of Diazepam Oral Disintegrating Tablet." International Journal of Pharmaceutical Sciences and Medicine 7, no. 9 (2022): 59–89. http://dx.doi.org/10.47760/ijpsm.2022.v07i09.005.

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This study reports the QbD on Pharmaceutical Development of Diazepam Oral Disintegrating Tablet. The concept of quality by design (QbD) has recently gained importance by application of design of experiments approach (DoE). QbD describes a pharmaceutical development approach especially in formulation design & development and manufacturing processes for the purpose of maintaining and improving the product quality. There are various elements of QbD are there such as Quality Target Product Profile (QTPP) ,Critical Quality Attributes (CQAS), Quality Risk (Assessment) Management (QRM), Design Sp

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Waman, Ravi, Gaurav Jain, Jeevan Patel, Ramakant Sharma, Shabnam Khan, and Rakesh Patel. "QbD Approach in Formulation Design and Evaluation of Metformin HCl Tablet." International Journal of Pharmaceutical Sciences and Medicine 7, no. 9 (2022): 27–58. http://dx.doi.org/10.47760/ijpsm.2022.v07i09.004.

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This study reports the QbD Approach in Formulation Design and Evaluation of Metformin HCl Tablet. The concept of quality by design (QbD) has recently gained importance by application of design of experiments approach (DoE). QbD describes a pharmaceutical development approach especially in formulation design & development and manufacturing processes for the purpose of maintaining and improving the product quality. There are various elements of QbD are there such as Quality Target Product Profile (QTPP) ,Critical Quality Attributes (CQAS), Quality Risk (Assessment) Management (QRM), Design S

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Witcher, Mark. "Quality Risk Management (QRM): Part II – Evaluating the Impact of Process Parameters on Critical Quality Attributes for Biopharmaceutical Products." BioProcessing Journal 15, no. 4 (2017): 22–31. http://dx.doi.org/10.12665/j154.witcher.q.

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Balli, Rathod* Harshal Navale. "Risk Assessment and Management Tools in QA." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 4594–604. https://doi.org/10.5281/zenodo.15537349.

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Risk assessment and management are crucial for guaranteeing the efficacy, safety, and quality of pharmaceuticals.  As regulatory scrutiny intensifies and pharmaceutical processes grow more complex, it is essential to incorporate strong risk management strategies into Quality Assurance (QA). The evolution of the industry necessitates proactive risk management approaches to reduce deviations, maintain compliance, and protect public health. Important conventional methods, such as Fault Tree Analysis (FTA), Hazard Analysis and Critical Control Points (HACCP), and Failure Mode and Effects Anal

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Balli, Rathod* Harshal Navale Dr. Sachin Datkhile. "Risk Assessment and Management Tools in QA." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 4594–604. https://doi.org/10.5281/zenodo.15537538.

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Risk assessment and management are crucial for guaranteeing the efficacy, safety, and quality of pharmaceuticals.  As regulatory scrutiny intensifies and pharmaceutical processes grow more complex, it is essential to incorporate strong risk management strategies into Quality Assurance (QA). The evolution of the industry necessitates proactive risk management approaches to reduce deviations, maintain compliance, and protect public health. Important conventional methods, such as Fault Tree Analysis (FTA), Hazard Analysis and Critical Control Points (HACCP), and Failure Mode and Effects Anal

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Aziz, Kaiser Jay. "Genome Editing: New, Emerging, and Interesting Developments for Clinical Applications." Journal of Biotechnology & Bioinformatics Research 3, no. 1 (2021): 1–4. http://dx.doi.org/10.47363/jbbr/2021(3)127.

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Principles of Genome Editing can be applied in the various areas of medical diagnosis and treatments ---from early process design/development through maintenance of the validated state during commercial manufacturing and post-marketing surveillance. Gene editing and clinical applications comprises of systematically assessing, monitoring, and reviewing manufacturing processes and subsequently monitoring measures to control output risks. Quality risk management (QRM) principles have been described in various FDA’s regulatory guidances for several aspects of good manufacturing practices (GMPs) su

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Saliy, O., O. Los, T. Palchevska, and K. Nebylytsia. "Implementation of the Quality by Design approach for developing the composition and the manufacturing technology of an injectable drug for intra-articular introduction." News of Pharmacy, no. 1(101) (February 1, 2021): 28–37. http://dx.doi.org/10.24959/nphj.21.44.

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Aim. To implement the Quality by Design (QbD) approach in order to develop the composition and the manufacturing technology of injectable hyaluronate sodium (HS) in combination with chondroitin sulfate (CS) for intra-articularintroduction. Materials and methods. The composition of the solution for injection was developed using samples of the active pharmaceutical ingredient (API) of HS and CS. The approaches of the ICH international guidelines were used to create the QbD protocol. The quality target product profile (QTPP) was developed based on the literature review, analysis of similar drugs

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Elmadhoun, Bassam, Rawidh Alsaidalani, and Frank Burczynski. "Quality Risk Management in the Final Operational Stage of Sterile Pharmaceutical Manufacturing: A Case Study Highlighting the Management of Sustainable Related Risks in Product Sterilization, Inspection, Labeling, Packaging, and Storage Processes." Sustainability 17, no. 4 (2025): 1670. https://doi.org/10.3390/su17041670.

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Quality risk management, commonly known as QRM, is designed to systematically assess, control, communicate, and review potential risks at every stage of the pharmaceutical manufacturing process. The preservation of consistent product quality across the entirety of the product’s life cycle is of paramount importance. The aim of this article is to formulate a best practice guide that will assist pharmaceutical manufacturers in comprehending and implementing the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q9: quality risk management pr

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Panda, Sagar Suman, Venkata Varaha Ravi Kumar Bera, and Biswajit Sahu. "Integrated Quality by Design (QbD) and Quality Risk Management (QRM) based Liquid Chromatographic Method Development and Validation for Estimation of Capecitabine in Pharmaceutical Dosage Form." Analytical Chemistry Letters 8, no. 5 (2018): 665–76. http://dx.doi.org/10.1080/22297928.2018.1516567.

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Tamboli, Firoj A., Prafull P. Mane, Rakesh B. Babaleshwar, et al. "From concept to compliance: The role of QbD in modern product development." Current Trends in Pharmacy and Pharmaceutical Chemistry 6, no. 4 (2025): 168–75. https://doi.org/10.18231/j.ctppc.2024.032.

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Pharmaceutical development is revolutionized by the Quality by Design (QbD) strategy, which replaces conventional trial-and-error procedures with a systematic, science-based approach that ensures product quality, safety, and efficacy. This article offers a comprehensive description of the key elements and instruments required to execute QbD, as specified by regulatory recommendations like ICH Q8 (R2) and ICH Q9. The construction of a Target Product Quality Profile (TPQP), which acts as a dynamic summary of the quality attributes required to achieve the intended product quality, safety, and eff

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Carlsson, Matts H. "Consistency in quality—A baseline for achieving total quality management." Quality and Reliability Engineering International 9, no. 3 (1993): 217–25. http://dx.doi.org/10.1002/qre.4680090309.

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Tyssedal, John. "Industrial Statistics: Quality management, application and development." Quality and Reliability Engineering International 23, no. 6 (2007): 641. http://dx.doi.org/10.1002/qre.880.

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Anthony (Tony) Cox, Louis. "Does Concern-Driven Risk Management Provide a Viable Alternative to QRA?" Risk Analysis 27, no. 1 (2007): 27–43. http://dx.doi.org/10.1111/j.1539-6924.2006.00857.x.

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Luchi, Andrea, Maria Filomena de Andrade Rodrigues, Nathalia da Silva Couvo, and Patricia Léo. "Fabricação de Medicamentos Estéreis: Diretrizes para Controle de Contaminação." Revista IPT: Tecnologia e Inovação 7, no. 25 (2024): 43–61. http://dx.doi.org/10.29327/2202814.7.25-5.

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Este artigo tem como objetivo descrever brevemente as diretrizes de Boas Práticas de Fabricação (BPF) para medicamentos estéreis no Brasil (Instrução Normativa IN 35/2019), e fazer uma breve explanação comparada com as alterações já definidas nas diretrizes do EU GMP Anexo 1 da Comissão Europeia e PIC/s. De acordo com a Comissão Europeia foi necessária a revisão das diretrizes (EU GMP Anexo 1 – Fabricação de Medicamentos Estéreis) para atendimento regulatório e desenvolvimento tecnológico, alinhado com o ICH Q9 (Gerenciamento de Riscos da Qualidade), e ICH Q10 (Sistema de Qualidade Farmacêutic

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Franceschini, Fiorenzo, and Domenico Maisano. "A survey of Quality Engineering-Management journals by bibliometric indicators." Quality and Reliability Engineering International 26, no. 6 (2009): 593–604. http://dx.doi.org/10.1002/qre.1083.

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Yılmaz, Şebnem, and Nimetullah Burnak. "An Economic Approach to the Management of High-Quality Processes." Quality and Reliability Engineering International 29, no. 5 (2012): 681–90. http://dx.doi.org/10.1002/qre.1417.

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Acikalin, Aydan. "Integration of safety management effectiveness into QRA calculations." Process Safety Progress 28, no. 4 (2009): 331–37. http://dx.doi.org/10.1002/prs.10323.

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Davis, Brendan. "Automated quality management systems in the electronics factory of the future." Quality and Reliability Engineering International 1, no. 2 (1985): 71–75. http://dx.doi.org/10.1002/qre.4680010204.

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Claver, Enrique, and Juan José Tarí. "The individual effects of total quality management on customers, people and society results and quality performance in SMEs." Quality and Reliability Engineering International 24, no. 2 (2008): 199–211. http://dx.doi.org/10.1002/qre.885.

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Fleischhammer, Werner. "Good quality at low cost: Trends in quality assurance." Quality and Reliability Engineering International 7, no. 6 (1991): 485–88. http://dx.doi.org/10.1002/qre.4680070608.

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Lascelles, D. M., and B. G. Dale. "A study of the quality management methods employed by U.K. automotive suppliers." Quality and Reliability Engineering International 4, no. 4 (1988): 301–9. http://dx.doi.org/10.1002/qre.4680040404.

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Crossfield, R. T., and B. G. Dale. "The use of expert systems in total quality management: An exploratory study." Quality and Reliability Engineering International 7, no. 1 (1991): 19–26. http://dx.doi.org/10.1002/qre.4680070107.

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Lee, Tat Y. "Total quality management in Hong Kong industry and its subsidiaries in China." Quality and Reliability Engineering International 9, no. 3 (1993): 179–83. http://dx.doi.org/10.1002/qre.4680090305.

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Manchikanti, Laxmaiah. "Assessment of Methodologic Quality of Randomized Trials of Interventional Techniques: Development of an Interventional Pain Management Specific Instrument." Pain Physician 3;17, no. 3;5 (2014): E263—E290. http://dx.doi.org/10.36076/ppj.2014/17/e263.

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Background: A major component of a systematic review is an assessment of the methodological quality and bias of randomized trials. The most commonly utilized methodological quality assessment and bias assessment for randomized trials is by the Cochrane Review Group. While this is not a “gold standard,” it is an indication of the current state-of-the-art review methodology. There is, however, no specific instrument to assess the methodological quality of manuscripts published for interventional techniques. Objectives: Our objective was to develop an instrument specifically for interventional pa

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Ganter, William A. "Quality in Design." Quality and Reliability Engineering International 4, no. 1 (1988): 4–6. http://dx.doi.org/10.1002/qre.4680040105.

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Hoffman, Lorrie L. "Choosing the best set of quality judges: A new quality tool." Quality and Reliability Engineering International 7, no. 6 (1991): 475–78. http://dx.doi.org/10.1002/qre.4680070606.

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Ferris-Prabhu, A. V. "Vlsi yield management and prediction." Quality and Reliability Engineering International 1, no. 4 (1985): 219–25. http://dx.doi.org/10.1002/qre.4680010403.

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Brombacher, Aarnout. "Quality, reliability and data..." Quality and Reliability Engineering International 34, no. 1 (2018): 1. http://dx.doi.org/10.1002/qre.2266.

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Prior, Derek. "Quality control information systems." Quality and Reliability Engineering International 1, no. 4 (1985): 227–34. http://dx.doi.org/10.1002/qre.4680010404.

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Malec, Henry A. "Benchmarking Quality and Reliability." Quality and Reliability Engineering International 7, no. 2 (1991): 61–62. http://dx.doi.org/10.1002/qre.4680070202.

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