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Related Concept Videos

Quality Control01:05

Quality Control

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Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
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Antimicrobial Effectiveness01:28

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The effectiveness of antimicrobial agents depends on various factors influencing their ability to eliminate microbial populations. Larger microbial populations require more time for complete eradication, emphasizing the importance of population size analysis when evaluating antimicrobial efficacy.Microbial resistance to antimicrobial agents varies significantly. Highly resilient microorganisms include endospores, gram-negative bacteria, and non-enveloped viruses, while prions are exceptionally...
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Antimicrobial Proteins01:23

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Antimicrobial proteins are important components of the immune system. They aid the body in combating pathogens by either killing them directly or hindering their replication processes. Four main types of antimicrobial substances are interferons, the complement system, iron-binding proteins, and antimicrobial proteins.
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Quality Assurance01:19

Quality Assurance

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Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
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Quality of Water01:19

Quality of Water

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In concrete preparation, the quality of water is paramount as it affects the strength and durability of the concrete. Potable water is usually preferred; however, it must not have excessive sodium or potassium to prevent compromising the concrete's integrity. Water quality is typically evaluated based on impurities such as dissolved solids, chlorides, and sulfates, and its pH value is ideally between 6 and 8. Even slightly acidic natural water may be acceptable unless it contains harmful...
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Microorganisms in Medicine and Therapeutics01:29

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Microorganisms play a fundamental role in vaccine development, gene therapy, and therapeutic production. Their biological properties are harnessed to advance medicine and public health. Beyond immunization, microorganisms contribute to gut health, antibiotic synthesis, and genetic disease treatment.Live Attenuated and Inactivated VaccinesLive attenuated vaccines, such as the measles, mumps, and rubella (MMR) vaccine, utilize weakened forms of pathogens to closely resemble natural infections.
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Application of the Intelligent High-Throughput Antimicrobial Sensitivity Testing/Phage Screening System and Lar Index of Antimicrobial Resistance
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Quality control programmes for veterinary antimicrobial medicines.

Helena Ponte1, Rui Santos Ivo1, Beatriz Silva-Lima2

  • 1INFARMED - Portuguese National Authority of Medicines and Health Products, IP Parque de Saúde de Lisboa, Av. do Brasil, 53, 1749-004, Lisboa, Portugal.

Regulatory Toxicology and Pharmacology : RTP
|August 22, 2018
PubMed
Summary
This summary is machine-generated.

Poor-quality antimicrobials contribute to antimicrobial resistance (AMR), a global threat. This paper examines regulatory quality control programs and their role in combating AMR, especially for veterinary medicines.

Keywords:
Antimicrobial resistanceFood-producing animalsMedicated feedMedicines qualityOne healthVeterinary antimicrobial medicines

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Area of Science:

  • Veterinary Pharmacology
  • Microbiology
  • Regulatory Science

Background:

  • Antimicrobial use offers health benefits but drives antimicrobial resistance (AMR), a complex global issue.
  • Injudicious antimicrobial use and a lack of new drug development, particularly for veterinary applications, exacerbate AMR.
  • Regulatory "One Health" action plans for AMR are increasing globally, incorporating resistance and consumption surveillance.

Purpose of the Study:

  • To link the issue of poor-quality antimicrobials to the development of antimicrobial resistance (AMR).
  • To review regulatory initiatives outside the European Union (EU) addressing antimicrobial quality and AMR, referencing World Health Organization (WHO) recommendations.
  • To stimulate discussion on the potential of quality control programs for antimicrobials in broader regulatory strategies against AMR.

Main Methods:

  • Literature review and analysis of existing regulatory frameworks and initiatives.
  • Examination of the European Union's (EU) approach to medicine quality control, contrasting it with conventional risk-based sampling.
  • Case study analysis of non-EU regulatory actions and WHO recommendations concerning antimicrobial quality and AMR.

Main Results:

  • The paper establishes a connection between substandard antimicrobial medicines and the rise of antimicrobial resistance (AMR).
  • Examples of regulatory approaches from outside the EU, aligned with WHO guidance, are presented.
  • The EU's quality control for medicines, based on Good Manufacturing Practices (GMP), differs from traditional risk-ranking methods.

Conclusions:

  • Ensuring the quality of antimicrobial medicines is crucial in the fight against antimicrobial resistance (AMR).
  • Regulatory quality control programs for antimicrobials may play a significant role beyond basic quality assurance, potentially supporting broader AMR containment strategies.
  • Further discussion is needed to explore the integration of antimicrobial quality control into comprehensive, coordinated regulatory actions against AMR.