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Related Concept Videos

Quality Assurance01:19

Quality Assurance

3.9K
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 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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Introduction to Statistical Process Control01:15

Introduction to Statistical Process Control

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Statistical Process Control (SPC) is a method used to monitor and control quality within processes, particularly in manufacturing and service delivery, by employing statistical methods. SPC aims to distinguish between natural (common cause) variation and variation due to specific changes or events (special cause), allowing for timely improvements and sustained quality. The control chart, a pivotal tool in SPC, visually displays data over time alongside a central line of upper and lower control...
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Control Systems01:10

Control Systems

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Control systems are everywhere in contemporary society, influencing diverse applications from aerospace to automated manufacturing. These systems can be found naturally within biological processes, such as blood sugar regulation and heart rate adjustment in response to stress, as well as in man-made systems like elevators and automated vehicles. A control system is essentially a network of subsystems and processes that collaboratively convert specific inputs into desired outputs.
At the heart...
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Data Validation01:15

Data Validation

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Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:
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Data Validation01:03

Data Validation

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Data validation is an essential part of a comprehensive assessment. Validation is confirming or verifying and opening the door to gathering more assessment data as it clarifies vague or unclear data. The process of checking and verifying the collected information is called data validation. The primary purpose of data validation is to ensure data is as free from error, bias, and misinterpretation as possible.
Nursing assessment guides are generally based on holistic models rather than medical...
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Quality Assurance and Quality Control, Part 2.

Michael J Akers

    International Journal of Pharmaceutical Compounding
    |December 31, 2015
    PubMed
    Summary

    Strict adherence to quality assurance and control procedures is crucial for sterile compounding, as highlighted by the New England Compounding Center tragedy. This article details compliance with United States Pharmacopeia standards for safe compounded sterile preparations.

    Area of Science:

    • Pharmaceutical Compounding
    • Quality Assurance
    • Sterile Preparations

    Background:

    • The New England Compounding Center incident underscores failures in quality assurance and control for sterile preparations.
    • This article is the second part of a series focusing on United States Pharmacopeia (USP) general chapters <797> and <1163>.

    Purpose of the Study:

    • To outline essential quality assurance requirements for compounding sterile preparations.
    • To ensure compliance with USP general chapters <797> and <1163>.

    Main Methods:

    • Discusses sterility testing protocols.
    • Completes the discussion on bacterial endotoxin testing initiated in Part 1.
    • Reviews United States Pharmacopeia <1163> on quality assurance.

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    Main Results:

    • Emphasizes the critical role of rigorous quality control in preventing contamination.
    • Highlights the importance of comprehensive documentation and inspection procedures.
    • Addresses advanced pharmaceutical quality systems.

    Conclusions:

    • Strict implementation of quality assurance and control is vital for sterile compounding safety.
    • Compliance with USP standards ensures the integrity and safety of compounded sterile preparations.
    • Continuous improvement in pharmaceutical quality systems is necessary.