scholarly journals History and Background of the Implementation of Good Manufacturing Practice Standards in the Pharmaceutical Industry (Review)

2020 ◽  
Vol 6 (9) ◽  
pp. 182-191
Author(s):  
N. Toktonalieva ◽  
I. Toktonaliev
Keyword(s):  
Pharmaceutical Industry ◽  
Scientific Literature ◽  
The United States ◽  
Good Manufacturing Practice ◽  
Pharmaceutical Products ◽  
Pharmaceutical Market ◽  
High Quality ◽  
Practice Standards ◽  
International Good

The volume of the global pharmaceutical market in 2018 amounted to 1.2 trillion US dollars, and by 2020 the global pharmaceutical market has grown to 1.5 trillion dollars. Countries such as the United States, Japan, Germany, Switzerland and Great Britain took the leading positions in the pharmaceutical market, while the market share of the member states of the Eurasian Economic Union (EAEU) in the world community was 2.6%. Further growth of the global pharmaceutical market is predicted by 5% annually, which may contribute to the rapid production and distribution of low-quality pharmaceutical products. One of the main goals of the country is to provide the population with effective, high-quality and safe medicines drugs to protect their health, since consumers cannot assess the quality of medicines on their own. To accomplish this task in developed and developing countries, the state regularly checks and evaluates the quality, efficacy, safety, as well as the main pharmacological effects of drugs at all stages of production. In the production of drugs, it is necessary to comply with the rules of Good Manufacturing Practice. Good Manufacturing Practice is one of the indispensable elements of a modern control and authorization system in the field of pharmaceutical circulation, no less important than the Pharmacopoeia or other state drug standards. Materials and methods. The review article presents an analysis of published scientific works of the last 15 years. To search for reliable information, we used scientific literature data from available and open sources placed in scientific electronic databases: Cyberleninka, PubMed, E-library, Medline, J-stage, Hindawi using the keywords: Good Manufacturing Practice, GMP, pharmaceutical industry, quality of medicines. Results. When analyzing scientific literature sources, special attention is paid to the relevance of this problem, the prerequisites for the introduction of Good Manufacturing Practice standards in the pharmaceutical industry and world practice. Conclusion. Summarizing the scientific literature data, we came to the conclusion that it is necessary to comply with the basic requirements of the international Good Manufacturing Practice standard for the production of high-quality drugs, which has a positive effect on the health of consumers.

scholarly journals Regulatory Comparative Quality Systems of India and USA and its Significance in Pharmaceutical Industry Facilities

2020 ◽  
Vol 11 (SPL4) ◽  
pp. 2457-2462
Author(s):  
Prabhakar V S ◽  
Beula Evangeline C ◽  
Aravindhanathan V ◽  
Sruthi N ◽  
Gowthamarajan K
Keyword(s):  
United States ◽  
Pharmaceutical Industry ◽  
The United States ◽  
Good Manufacturing Practice ◽  
Pharmaceutical Products ◽  
Primary Objective ◽  
Regulatory Requirements ◽  
Quality Management Systems ◽  
Pharmaceutical Manufacturers ◽  
Speed Up

The intentions of the current study are to compare the regulatory requirements of USFDA and CDSCO-Schedule M in GMP with significance to the pharmaceutical industry to speed up the criteria for enforcement to facilitate the regulatory approval of specified pharmaceutical products in the United States and India. The literature search is done using different resources, such as regulatory authority websites, pharmaceutical review articles, journals and public domains. To discuss the numerous dilemmas, root causes and challenges confront by pharmaceutical companies and to suggest remedial and pro-active measures to GMP issues and all pharmaceutical manufacturers are required to develop and enforce effective quality control systems in order to ensure quality. Whereas the regulated markets like the United States have well-established guidance compared to emerging markets like India on good manufacturing practice compliance, to assess the effectiveness of this quality management systems, inspections are carried out on manufacturing units. The primary objective of the analysis is to differentiate between the type of application or license that causes the inspection and the outcome of the inspection and to also provide enough details identified by the authority during the evaluation.

scholarly journals A global scientific literature of research on water quality indices: trends, biases and future directions

2014 ◽  
Vol 26 (3) ◽  
pp. 245-253 ◽  
Author(s):  
Maria Tereza Ribeiro Alves ◽  
Fabrício Barreto Teresa ◽  
João Carlos Nabout
Keyword(s):  
Water Quality ◽  
Linear Models ◽  
Scientific Literature ◽  
Information Criterion ◽  
The United States ◽  
Water Index ◽  
Resource Managers ◽  
Quality Of Water ◽  
Number Of Publications

AIM: Water quality has been the subject of many recent studies, moreover, the physical, chemical and biological parameters of water are used to investigate water quality and can be combined into a single index, the Water Quality Index (WQI), for use by water resource managers and the general public. The aim of this study was to use scientometrics to evaluate how water quality has been addressed in the international scientific literature. METHOD: For the quantitative analysis of the publications on WQI, we used the search database SCOPUS (http://www.scopus.com). The search was performed using the words "QUALIT* WATER* INDEX*" in papers published in all databases (through 2011). RESULTS: We found 554 articles that dealt with the use of WQI the number of publications has increased significantly over the last 20 years. India had the most studies, with 177 articles, followed by China, Brazil and the United States. These four countries together published 57% of studies on WQI. We generated 15 linear models to explain the number of publication by study sit (country). According to the Akaike Information Criterion (AIC), the best model to explain the number of publications by country was the model that combined Sanitation and Public Supply. CONCLUSION: Finally, this paper presents the state of scientific literature on WQI and demonstrates the growing interest of the scientific community in this issue, which is certainly due to the importance of the quantity and quality of water for human supply, economics, health and the conservation of water resources.

Pharmaceutical Regulation in the European Union

2018 ◽  
Author(s):  
Stuart O. Schweitzer ◽  
Z. John Lu
Keyword(s):  
European Union ◽  
Drug Approval ◽  
Good Clinical Practice ◽  
The United States ◽  
Good Manufacturing Practice ◽  
Pharmaceutical Products ◽  
European Medicines Agency ◽  
Regulatory Regime ◽  
The European Union ◽  
Regulatory Pathways

The main scientific and technical aspects of new drug registration, including pathways to marketing authorization approval, clinical study design and method, and requirement of and specifications for Good Clinical Practice, Good Laboratory Practice, and Good Manufacturing Practice, are all quite similar between Europe and the United States. Differences do exist, however. This chapter provides a closer examination of the drug regulatory regime in the European Union. After providing a brief history of the European Medicines Agency, the chapter examines the agency’s organizational structure and role in ensuring the safety and efficacy of pharmaceutical products for Europe, and discusses the regulatory pathways for generics and biosimilars in the EU. The chapter also looks at recent trends in international drug approval lags.

scholarly journals National Survey of US HIV Clinicians: Knowledge and Attitudes About the Affordable Care Act and Opinions of its Impact on Quality of Care and Barriers to Care

2020 ◽  
Vol 7 (7) ◽  
Author(s):  
Kathleen A McManus ◽  
Joshua Ferey ◽  
Elizabeth Farrell ◽  
Rebecca Dillingham
Keyword(s):  
Quality Care ◽  
Binary Logistic Regression ◽  
The United States ◽  
Hiv Care ◽  
Medicaid Expansion ◽  
High Quality ◽  
High Quality Care ◽  
Knowledge And Attitudes ◽  
Hiv Epidemic

Abstract Background The Affordable Care Act’s (ACA’s) major reforms started in 2014. In addition to assessing HIV clinicians’ ACA knowledge and attitudes, this study aims to evaluate HIV clinicians’ perspectives on whether the ACA has impacted the quality of HIV care and whether it addresses the main barriers to HIV care. Methods HIV clinicians were emailed a survey weblink in 2018. Descriptive statistics, Mann-Whitney U tests, and binary logistic regression were performed. Results Of the 211 survey participants, the majority (70%) answered all 4 knowledge questions correctly. About 80% knew correctly whether their state had expanded Medicaid. Participants from Medicaid expansion states were more likely to report an improved ability to provide high-quality care compared with participants from Medicaid nonexpansion states (50% vs 34%; P = .01). The average response to whether the ACA addresses the main barriers to HIV care was neutral and did not differ based on Medicaid status. The top 3 main barriers to HIV care cited were mental health, substance use, and transportation. Conclusions HIV clinicians in Medicaid expansion states were more likely to report an improved ability to provide high-quality care since ACA implementation compared with those in Medicaid nonexpansion states. However, HIV clinicians across the United States are concerned that the ACA does not address the main barriers to HIV care. To be successful, the “Ending the HIV Epidemic” initiative should address these identified barriers.

scholarly journals Dietary and herbal supplements for weight loss: assessing the quality of patient information online

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Jeremy Y. Ng ◽  
Saad Ahmed ◽  
Catherine Jiayi Zhang
Keyword(s):  
Weight Loss ◽  
Health Information ◽  
Healthcare Providers ◽  
The United States ◽  
Consumer Health Information ◽  
Consumer Health ◽  
High Quality ◽  
The Mean ◽  
The Impact

Abstract Background Given the high prevalence of dietary and herbal supplement (DHS) use in tandem with the growing ease of internet access, patients commonly search online for consumer health information about these products. One common reason for DHSs use includes weight loss. Healthcare providers need to be aware of the quality of online information about DHSs for weight loss so they can adequately counsel their patients and provide them with guidance surrounding the identification of high-quality information resources. This study aimed to assess the quality of online DHSs consumer health information for weight loss that a “typical” patient might access online. Methods Six search terms were used to generate the first 20 websites on the Google search engine in four countries: Australia, Canada, the United Kingdom, and the United States (n = 480 websites). After applying exclusion criteria, eligible websites were quality assessed using the DISCERN instrument. This tool is comprised of 16 questions, each evaluated on a 5-point scale. The averages and standard deviations for each DISCERN instrument item, in addition to overall summed scores between 15 and 75 were calculated. Results Across 87 eligible websites, the mean summed score was 44.80 (SD = 11.53), while the mean overall DISCERN score of each website was 2.72 (SD = 0.99). In general, websites detailed and achieved their specified aims and described treatment benefits. However, most websites failed to describe the impact of treatment on overall quality of life and the impact of a no treatment option. The highest-scoring websites were largely government or health portal websites, while the lowest-scoring websites were largely commercial in nature. Conclusion High variability in DISCERN instrument scores was found across all websites assessed. Healthcare providers should be aware of the fact that their patients may be accessing misinformation online surrounding the use of DHSs for weight loss. Therefore, it is important for healthcare providers to ensure that they are providing their patients with guidance on how to identify high-quality resources online, in order that safe, effective, and evidence-based decisions are made surrounding the use of DHSs for weight loss.

scholarly journals International trade between Hungary and Russia within the development of the pharmaceutical industry

2022 ◽  
Vol 7 (4) ◽  
pp. 79-92
Author(s):  
R. R. Asmyatullin ◽  
I. A. Aydrus ◽  
Nagy Szabolcs
Keyword(s):  
Pharmaceutical Industry ◽  
Global Economy ◽  
Pharmaceutical Products ◽  
Pharmaceutical Market ◽  
Economic Potential ◽  
Trade Relations ◽  
Manufactured Products ◽  
Innovative Products ◽  
Political Differences ◽  
The Eu

The global pharmaceutical market is one of the most innovative and dynamically developing sectors of the global economy. In addition, this industry can be considered highly profitable. Its role has especially increased in the context during the coronavirus pandemic. This article examines trade relations between Russia and Hungary in the pharmaceutical sector. For the Hungarian economy, the pharmaceutical industry is one of the traditional and most innovative sectors of the economy: about 86% of the manufactured products are exported. Hungary is among the top 20 largest exporting and importing countries of pharmaceutical products. The main partners of Hungary are the EU countries. Russia remains an important partner of Hungary in the export of pharmaceutical products, however, it we should note the downward trend of the Russian share in Hungarian exports, due to the sanctions policy on the part of the EU. After the imposition of sanctions in 2014, the growth rate of the Russian pharmaceutical market slowed down, which also negatively affected the volume of trade cooperation with European partners. Russia has traditionally been a major importer in the global pharmaceutical market. An important problem is the reduction of drug import dependence and the expansion of exports. For Russia, this will be possible thanks to the development of unique innovative products. Hungary is an attractive country for the development and expansion of Russia's trade relations in the global pharmaceutical market. For both countries, the pharmaceutical industry is strategically important. The situation with the coronavirus pandemic has shown that political differences can be leveled. Hungary became the first European country to conclude a contract with Russia for the supply of Sputnik V coronavirus vaccine. Thus, there is a high economic potential to make up for the lost pharmaceutical relationship between the two countries.

scholarly journals A Mapping Literature Review of Medical Cannabis Clinical Outcomes and Quality of Evidence in Approved Conditions in the United States, from 2016 to 2019

2021 ◽  
Author(s):  
Sebastian Jugl ◽  
Aimalohi Okpeku ◽  
Brianna Costales ◽  
Earl Morris ◽  
Golnoosh Alipour-Harris ◽  
...  
Keyword(s):  
United States ◽  
Chronic Pain ◽  
Systematic Reviews ◽  
The United States ◽  
Evidence Base ◽  
Medical Cannabis ◽  
High Quality ◽  
Quality Of Evidence ◽  
Study Setting

Background: Medical cannabis is available to patients by physician order in two-thirds of the United States (U.S.) as of 2020, but remains classified as an illicit substance by federal law. States that permit medical cannabis ordered by a physician typically require a diagnosed medical condition that is considered qualifying by respective state law. Objectives: To identify and map the most recently (2016-2019) published clinical and scientific literature across approved conditions for medical cannabis, and to evaluate the quality of identified recent systematic reviews. Methods: Literature search was conducted from five databases (PubMed, Embase, Web of Science, Cochrane, and ClinicalTrials.gov), with expansion and update from the National Academies of Sciences, Engineering, and Medicine’s (NASEM) comprehensive evidence review through 2016 of the health effects of cannabis on several conditions. Following consultation with experts and stakeholders, 11 conditions were identified for evidence evaluation: amyotrophic lateral sclerosis (ALS), autism, cancer, chronic pain, Crohn’s disease, epilepsy, glaucoma, HIV/AIDS, multiple sclerosis (MS), Parkinson’s disease, and posttraumatic stress disorder (PTSD). The following exclusion criteria were imposed: preclinical focus, non-English language, abstracts only, editorials/commentary, case studies/series, and non-U.S. study setting. Data extracted from studies included: study design type, outcome, intervention, sample size, study setting, and reported effect size. Studies classified as systematic reviews with or without meta-analysis were graded using the AMSTAR-2 tool by two raters to evaluate the quality of evidence, with additional raters to resolve cases of evidence grade disagreement. Results: A total of 438 studies were included after screening. Five completed randomized controlled trials (RCTs) were identified, and an additional 11 trials were ongoing, and 1 terminated. Cancer, chronic pain, and epilepsy were the most researched topic areas, representing more than two-thirds of all reviewed studies. The quality of evidence assessment for each condition suggests that few high-quality systematic reviews are available for most conditions, with the exceptions of MS, epilepsy, and chronic pain. In those areas, findings on chronic pain are mostly in alignment with the previous literature, suggesting that cannabis or cannabinoids are potentially beneficial in treating chronic neuropathic pain. In epilepsy, findings suggest that cannabidiol is potentially effective in reducing seizures in pediatric patients with drug-resistant Dravet and Lennox-Gastaut syndromes. In MS, recent high-quality systematic reviews did not include new RCTs, and are therefore not substantially expanding the evidence base. In sum, the most recent clinical evidence suggests that for most of the conditions assessed, we identified few studies of substantial rigor and quality to contribute to the evidence base. However, there are some conditions for which significant evidence suggests that select dosage forms and routes of administration likely have favorable risk-benefit ratios (i.e., epilepsy and chronic pain), with the higher quality of evidence for epilepsy driven by FDA-approved formulations for cannabis-based seizure treatments. Conclusion: The body of evidence for medical cannabis requires more rigorous evaluation before consideration as a treatment option for many conditions and evidence necessary to inform policy and treatment guidelines is currently insufficient for many conditions.

scholarly journals Online Information About Periviable Birth: Quality Assessment (Preprint)

2018 ◽  
Author(s):  
Adriane F Haragan ◽  
Carly A Zuwiala ◽  
Katherine P Himes
Keyword(s):  
Medical Information ◽  
The United States ◽  
The Internet ◽  
Online Information ◽  
High Quality ◽  
Comfort Care ◽  
Treatment Choices ◽  
News Stories ◽  
Google Search

BACKGROUND Over 20,000 parents in the United States face the challenge of participating in decisions about whether to use life support for their infants born on the cusp of viability every year. Clinicians must help families grasp complex medical information about their baby’s immediate prognosis as well as the risk for significant long-term morbidity. Patients faced with this decision want supplemental information and frequently seek medical information on the Internet. Empirical evidence about the quality of websites is lacking. OBJECTIVE We sought to evaluate the quality of online information available about periviable birth and treatment options for infants born at the cusp of viability. METHODS We read a counseling script to 20 pregnant participants that included information typically provided by perinatal and neonatal providers when periviable birth is imminent. The women were then asked to list terms they would use to search the Internet if they wanted additional information. Using these search terms, two reviewers evaluated the content of websites obtained via a Google search. We used two metrics to assess the quality of websites. The first was the DISCERN instrument, a validated questionnaire designed to assess the quality of patient-targeted health information for treatment choices. The second metric was the Essential Content Tool (ECT), a tool designed to address key components of counseling around periviable birth as outlined by professional organizations. DISCERN scores were classified as low quality if scores were 2, fair quality if scores were 3, and high quality if scores were 4 or higher. Scores of 6 or higher on the ECT were considered high quality. Interreviewer agreement was assessed by calculated kappa statistic. RESULTS A total of 97 websites were reviewed. Over half (57/97, 59%) were for-profit sites, news stories, or personal blogs; 28% (27/97) were government or medical sites; and 13% (13/97) were nonprofit or advocacy sites. The majority of sites scored poorly in DISCERN questions designed to assess the reliability of information presented as well as data regarding treatment choices. Only 7% (7/97) of the websites were high quality as defined by the DISCERN tool. The majority of sites did not address the essential content defined by the ECT. Importantly, only 18% of websites (17/97) indicated that there are often a number of reasonable approaches to newborn care when faced with periviable birth. Agreement was strong, with kappa ranging from .72 to .91. CONCLUSIONS Most information about periviable birth found on the Internet using common search strategies is of low quality. News stories highlighting positive outcomes are disproportionately represented. Few websites discuss comfort care or how treatment decisions impact quality of life.

scholarly journals The Impact of COVID-19 Across Nursing Homes That Disproportionally Serve Minority Residents

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 241-241
Author(s):  
Amit Kumar ◽  
Indrakshi Roy ◽  
Amol Karmarkar ◽  
Kimberly Erler ◽  
James Rudolph ◽  
...  
Keyword(s):  
Older Adults ◽  
Nursing Homes ◽  
The United States ◽  
Structural Racism ◽  
High Quality ◽  
Total Death ◽  
The Life Course ◽  
The Impact ◽  
Related Mortality

Abstract The Coronavirus-2019 (COVID-19) pandemic has disproportionally affected communities of color and older adults in the United States. Nursing homes (NHs) have reported over 130,000 COVID-19 deaths (or one-fourth of all US deaths) circa March 2021, a high share of the nation’s total death count (CMS COVID-19 NH Data). These inequities partially driven by barriers to care, segregation and structural racism have resulted in the unequal impact of COVID-19 across NHs (Li et al., 2020). In this presentation, I will describe NHs that disproportionally care for minority residents and the effect of NH composition on COVID-19-related mortality and outcomes. In 2020, minority older adults were less likely to have access to high quality facilities. From June – August, NHs with a high proportion of minority residents reported higher COVID-19 mortality rates per 1000 residents. Equal access to high quality of care across the life-course among racial and ethnic groups is needed.

Patient Centric Healthcare InformationSystems in the U.S.

2011 ◽  
pp. 498-506
Author(s):  
Nilmini Wickramasinghe
Keyword(s):  
Quality Of Healthcare ◽  
The United States ◽  
Final Report ◽  
Institute Of Medicine ◽  
High Quality ◽  
Quality Healthcare ◽  
Improving Patient Care ◽  
The U.S ◽  
Patient Centric

Healthcare expenditure is increasing exponentially, and reducing this expenditure (i.e., offering effective and efficient quality healthcare treatment) is becoming a priority not only in the United States, but also globally (Bush, 2004; Oslo Declaration, 2003;Global Medical Forum, 2005). In the final report compiled by the Committee on the Quality of Healthcare in America (Institute of Medicine, 2001), it was noted that improving patient care is integrally linked to providing high quality healthcare.

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