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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.
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
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Drug Products: Biologics, Biosimilars and Interchangeables01:28

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Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

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Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
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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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Improving Biopharmaceutical Safety through Verification-Based Quality Control.

Yihua Bruce Yu1, Marc B Taraban1, Weizhen Wang2

  • 1Department of Pharmaceutical Sciences, Bio- and Nano-Technology Center, University of Maryland School of Pharmacy, Baltimore, MD, USA.

Trends in Biotechnology
|September 26, 2017
PubMed
Summary
This summary is machine-generated.

Biopharmaceutical quality control needs improvement. Shifting from inference-based to verification-based methods, like water proton NMR (wNMR), can enhance safety by detecting rare defects in every vial.

Keywords:
NMRbiopharmaceuticalspoint-of-care inspectionquality controlreal-world datatransverse relaxation ratevaccines

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Area of Science:

  • Pharmaceutical Science
  • Biotechnology
  • Analytical Chemistry

Background:

  • Current pharmaceutical quality control (QC) relies on inferring the quality of untested units from tested ones.
  • This inference-based QC paradigm, applied to both small-molecule drugs and biopharmaceuticals, risks missing rare pre-release defects and post-release issues.
  • Biopharmaceuticals, due to their inherent complexity and fragility, are particularly susceptible to manufacturing errors and post-release damage, heightening the risk.

Purpose of the Study:

  • To propose a transition from inference-based to verification-based quality control for biopharmaceuticals.
  • To enhance the safety and reliability of biopharmaceutical products throughout their lifecycle.
  • To introduce the concept of developing non-destructive inspection technologies for comprehensive quality verification.

Main Methods:

  • Discusses the limitations of current inference-based quality control (QC) for biopharmaceuticals.
  • Proposes a shift towards verification-based QC for improved biopharmaceutical safety.
  • Introduces non-destructive inspection technologies as a means to verify the quality of every unit.

Main Results:

  • Inference-based QC may fail to detect rare defects in biopharmaceuticals.
  • Biopharmaceutical complexity and fragility increase the likelihood of defects.
  • Verification-based QC offers a more robust approach to ensuring product quality and safety.

Conclusions:

  • A transition to verification-based quality control is crucial for improving biopharmaceutical safety.
  • Developing non-destructive inspection technologies is key to implementing this new QC paradigm.
  • Water proton NMR (wNMR) is presented as a potential technology for non-destructive quality verification.