scholarly journals Data Integrity Violations: A Challenge to the Pharmaceutical Industry

2020 ◽  
Vol 11 (01) ◽  
pp. 196-198
Author(s):  
Himani Jaiswal ◽  
Muddukrishna B. S. ◽  
Girish Pai Kulyadi
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Data Integrity ◽  
Regulatory Compliance ◽  
China And India ◽  
The Us ◽  
Standard Operating ◽  
Data Lifecycle ◽  
Us Fda ◽  
The Impact

Data integrity refers to data reliability throughout the data lifecycle. Terminology “ALCOA” means that the data should be attributable, legible, contemporaneously recorded, original, and accurate. “ALCOA Plus” was introduced later. Violation of the integrity of data is termed as a breach of data integrity. It can take place in various fields, but not limited to manufacturing, quality control (QC), quality assurance (QA), and research. Some of the reasons for breach in data integrity are fabrication or duplication of data, out of specification, out of trend, back-dating, manipulation of data, inadequate standard operating procedures (SOPs), common usernames, and shared passwords. A study to assess the impact of data integrity violations based on the US FDA warning letters was conducted. The majority of data integrity breaches belonged to QC. The frequency of letters based on the country has been presented in the form of a graph. China and India received the highest number of letters for breach of data integrity in the year 2018 and 2017 respectively. It can be concluded that it is important to enforce data integrity and develop strategies for the same. The study is beneficial to understand the reason, affected field of work and remediation methods for data integrity, and improve regulatory compliance.

scholarly journals Gap-analysis of DNA barcoding in ERMS reference libraries for ascidians and cnidarians

2020 ◽  
Author(s):  
Guy Paz ◽  
Baruch Rinkevich
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Dna Barcoding ◽  
Regulatory Compliance ◽  
Marine Biodiversity ◽  
Sequence Information ◽  
Reference Library ◽  
Knowledge Gaps ◽  
Ecosystem Monitoring ◽  
Wide Range

Abstract BackgroundAll-inclusive DNA barcoding libraries in the storage and analysis platform of the BOLD (Barcode of Life Data) system are essential for the study of the marine biodiversity and are pertinent for regulatory purposes, including ecosystem monitoring and assessment, such as in the context of the EU Water Framework Directive (WFD) and the Marine Strategy Framework Directive (MSFD). Here we investigate knowledge gaps in the lists of DNA barcoded organisms within two inventories, Cnidaria (Anthozoa and Hydrozoa) and Ascidiacea from the reference libraries of the European Register of Marine Species (ERMS) dataset (402 ascidians and 1200 cnidarian species). ERMS records were checked species by species, against publicly available sequence information and other data stored in BOLD system. As the available COI barcode data adequately covers just a small fraction of the ERMS reference library, it is of importance to employ quality control on existing data, to close the knowledge gaps and purge errors off BOLD.ResultsResults revealed that just 22.9% and 29.2% of the listed ascidians and cnidarians species, respectively, are BOLD barcodes of which, 58.4% and 52.3% of the seemingly barcoded species, respectively, were noted to have complete BOLD pages. Thus, only 11.44% of the tunicate and 17.07% of the cnidarian data in the ERMS lists are of high quality. Deep analyses revealed seven common types of gaps in the list of the barcoded species in addition to a wide range of discrepancies and misidentifications, discordances and errors primarily in the GenBank mined data as with the BINs assignments, among others.ConclusionsGap knowledge in barcoding of important taxonomic marine groups exist and in addition, quality management elements (quality assurance and quality control) were not employed when using the list for national monitoring projects, for regulatory compliance purposes and other purposes. Even though BOLD is the most trustable DNA barcoding reference library, worldwide projects of DNA barcoding are needed to close these gaps of mistakes, verifications, missing data and unreliable sequencing labs. Tight quality control and quality assurance is important to close the knowledge gaps of Barcoding of the European recommended ERMS reference library.

Supplier Quality Assurance Systems: A Study in the Nuclear Industry

1988 ◽  
Vol 202 (4) ◽  
pp. 205-212 ◽  
Author(s):  
A J Singer ◽  
G F Churchill ◽  
B G Dale
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Cost Effectiveness ◽  
High Risk ◽  
Professional Competence ◽  
Quality System ◽  
Nuclear Industry ◽  
The Cost ◽  
The Impact ◽  
Stringent Quality

This paper reports the results of a study which investigated the impact of quality assurance on 13 suppliers to the nuclear industry. The purpose of the study was to determine the benefits and problems of applying quality assurance in the supply of high risk plant items and material for nuclear installations. The paper discusses the problems facing the industry including: multiple audits and inspections, the irritation with having to contend with two quality system standards (namely BS 5750 and BS 5882) and the cost effectiveness of the more stringent quality system and quality control surveillance requirements imposed by the nuclear industry. It is also pointed out that companies supplying non-nuclear industrial customers were dissatisfied with the qualifications, experience and professional competence of some auditors and many inspectors.

Quality Control, Quality Assurance, and Business Continuity Plan in PACS

2010 ◽  
pp. 123-138
Author(s):  
Carrison K.S. Tong ◽  
Eric T.T. Wong
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Real World ◽  
Business Continuity ◽  
System Operation ◽  
Critical Part ◽  
And Performance ◽  
The Impact ◽  
Avoidable Risk ◽  
Pacs System

As PACS gains widespread use, the importance of Quality Control (QC), Quality Assurance (QA), and Business Continuity Plan (BCP) in PACS is rising. The purpose of QC/QA is to measure the quality and performance of a PACS for minimizing the chance of getting any avoidable risk. However, in the real world, there is still some risk in any complicated system. Therefore, BCP is used to reduce the impact and downtime of hospital PACS system operation due to changes or failures in the company operation procedure. The purpose of BCP is to make sure that the critical part of PACS system operation is not affected by critical failure or disaster.

scholarly journals Abuse-deterrent opioid analgesics: a guide for clinicians

2020 ◽  
Vol 10 (1) ◽  
pp. 55-62 ◽  
Author(s):  
Adam J Carinci
Keyword(s):  
Real World ◽  
Opioid Analgesics ◽  
Prescription Opioid ◽  
Pharmacokinetic Studies ◽  
Regulatory Issues ◽  
The Us ◽  
Us Fda ◽  
The Impact ◽  
Prescription Opioid Abuse

The US FDA has encouraged the development of abuse-deterrent formulations (ADFs) of opioid analgesics as one component in a comprehensive effort to combat prescription opioid abuse. Guidance issued by the FDA outlines three types of premarket studies for evaluating abuse deterrence: laboratory-based in vitro manipulation and extraction studies, pharmacokinetic studies and human abuse potential studies. After approval, postmarket studies are needed to evaluate the impact of an ADF product on abuse in real-world settings. This review summarizes the regulatory issues involved in the development of ADF opioids and clarifies abuse-deterrence claims in product labels, in order to assist clinicians in critically evaluating the available evidence pertaining to the abuse-deterrent features of opioid analgesics.

scholarly journals Gap analysis of DNA barcoding in ERMS reference libraries for ascidians and cnidarians

2021 ◽  
Vol 33 (1) ◽  
Author(s):  
Guy Paz ◽  
Baruch Rinkevich
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Dna Barcoding ◽  
Regulatory Compliance ◽  
Marine Biodiversity ◽  
Sequence Information ◽  
Reference Library ◽  
Knowledge Gaps ◽  
Ecosystem Monitoring ◽  
Wide Range

Abstract Background All-inclusive DNA-barcoding libraries in the storage and analysis platform of the BOLD (Barcode of Life Data) system are essential for the study of the marine biodiversity and are pertinent for regulatory purposes, including ecosystem monitoring and assessment, such as in the context of the EU Water Framework Directive (WFD) and the Marine Strategy Framework Directive (MSFD). Here, we investigate knowledge gaps in the lists of DNA barcoded organisms within two inventories, Cnidaria (Anthozoa and Hydrozoa) and Ascidiacea from the reference libraries of the European Register of Marine Species (ERMS) dataset (402 ascidians and 1200 cnidarian species). ERMS records were checked species by species, against publicly available sequence information and other data stored in BOLD system. As the available COI barcode data adequately cover just a small fraction of the ERMS reference library, it is of importance to employ quality control on existing data, to close the knowledge gaps and purge errors off BOLD. Results Results revealed that just 22.9% and 29.2% of the listed ascidians and cnidarians species, respectively, are BOLD barcodes of which 58.4% and 52.3% of the seemingly barcoded species, respectively, were noted to have complete BOLD pages. Thus, only 11.44% of the tunicate and 17.07% of the cnidarian data in the ERMS lists are of high quality. Deep analyses revealed seven common types of gaps in the list of the barcoded species in addition to a wide range of discrepancies and misidentifications, discordances, and errors primarily in the GenBank mined data as with the BINs assignments, among others. Conclusions Gap knowledge in barcoding of important taxonomic marine groups exists, and in addition, quality management elements (quality assurance and quality control) were not employed when using the list for national monitoring projects, for regulatory compliance purposes and other purposes. Even though BOLD is the most trustable DNA-barcoding reference library, worldwide projects of DNA barcoding are needed to close these gaps of mistakes, verifications, missing data, and unreliable sequencing labs. Tight quality control and quality assurance are important to close the knowledge gaps of Barcoding of the European recommended ERMS reference library.

scholarly journals The Impact of Process Quality and Quality Control on Organizational Competitiveness at 5-star hotels in Dubai

2021 ◽  
Vol 1 (1) ◽  
pp. 54-68
Author(s):  
Ali Alzoubi
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Research Study ◽  
Hotel Industry ◽  
Process Quality ◽  
Perfect Competition ◽  
The Impact ◽  
Practical Field

Hotel industry is seeing many challenges because of the market challenges due to perfect competition market. Among these challenges quality assurance and quality control has significant impact because these factors determine the competitiveness level of the organization. In this research study we explained the hotel industry in the light of process quality and quality control. Interview was arranged and data was collected for interpretation. Results stated that process quality and quality control has significant impact on attaining competitiveness in hotel industry. This study can contribute a lot not just in theoretical field but also in practical field where the hotels can evaluate their own performance and the lacking in their own strategies.

scholarly journals The Impact of Animal Agriculture on Human Health

2021 ◽  
Author(s):  
Andrea Kassay
Keyword(s):  
Antibiotic Resistance ◽  
Infectious Diseases ◽  
Health Problems ◽  
Human Diseases ◽  
Meat Industry ◽  
Animal Agriculture ◽  
The Us ◽  
Excessive Consumption ◽  
Us Fda ◽  
The Impact

Animal agriculture contributes to many health problems that exist today, such as the spread of infectious diseases, antibiotic resistance, and chronic human diseases like heart disease and cancer. With regards to infectious diseases, most modern day infections were unknown before the domestication of animals. Industrial agriculture forces a large number of genetically similar animals into unsanitary situations, providing the perfect conditions for viruses to emerge and spread to different species. With regards to antibiotic resistance, the US FDA estimates that each year, 80% of microbial drugs are sold to the meat industry. Countries that have the most microbial resistance also have the highest use of antimicrobials, such as penicillins, tetracyclines, and sulfonamides in animal agriculture. With regards to chronic human diseases, there is extensive evidence that the excessive consumption of animal-based products can lead to chronic diseases such as cardiovascular disease and some types of cancer. The purpose of this article is to further discuss how animal agriculture may be a cause of these current health problems and how adopting a plant-based diet can be a potential solution.

scholarly journals Daratumumab utilization and cost analysis among patients with multiple myeloma in a US community oncology setting

2021 ◽  
Author(s):  
Lucio N Gordan ◽  
Stanley M Marks ◽  
Mei Xue ◽  
Neil Nagovski ◽  
J Hunter Lambert ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Treatment Patterns ◽  
Cost Of Care ◽  
Dosing Schedule ◽  
Community Oncology ◽  
Improved Outcomes ◽  
The Us ◽  
Us Fda ◽  
The Cost ◽  
The Impact

Background: The introduction of daratumumab into the treatment of multiple myeloma has improved outcomes in patients; however, community oncologists often dose more frequently than the US FDA-approved label. Materials and methods: Integra analyzed its database to elucidate daratumumab treatment patterns and the impact of increased utilization on the cost of care for multiple myeloma. Results: Following week 24, 671 (65%) of 1037 patients remained on daratumumab-containing regimens, with 330 patients continuing more frequent treatments than the expected once-every-4-weeks dosing described in the standard dosing schedule. Patients received an average of 14% more daratumumab doses than the FDA-approved label indicates, increasing the 1-year daratumumab costs by an estimated US$31,353. Conclusion: Daratumumab is utilized more frequently than the FDA-recommended dosing, leading to higher multiple myeloma treatment costs.

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