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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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Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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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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In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

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Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
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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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Contaminants and Errors01:16

Contaminants and Errors

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Effective sample preparation is crucial for accurate and reliable laboratory analysis. During this process, two significant sources of error can arise: concentration bias from improper sample splitting and contamination caused by methods used to reduce particle size, such as grinding or homogenization. Identifying and minimizing these potential errors is crucial to ensuring the validity of the analysis.
Another key consideration is determining the appropriate number of samples required to...
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Using Hospital Laboratory Services to Perform Quality-control Testing on Compounded Preparations.

Ronald F Donnelly

    International Journal of Pharmaceutical Compounding
    |January 19, 2016
    PubMed
    Summary

    Utilizing hospital laboratories for quality control testing is a cost-effective strategy for compounding pharmacies. Validated methods ensure accurate potency testing, meeting compounding standards and enhancing preparation quality.

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    Area of Science:

    • Pharmaceutical Sciences
    • Quality Control
    • Compounding Pharmacy

    Background:

    • Successful sterile and nonsterile compounded preparations depend on critical factors, including accurate preparation potency.
    • Expanding quality-control programs is essential for compounding pharmacies to meet industry standards.

    Purpose of the Study:

    • To evaluate the feasibility and benefits of using hospital laboratories for quality-control testing in compounding pharmacies.
    • To demonstrate how external laboratory utilization can support accurate potency determination and overall preparation quality.

    Main Methods:

    • The study proposes leveraging existing hospital laboratory infrastructure and expertise.
    • Emphasis is placed on the necessity of validating all testing methodologies used by the external laboratory.
    • Cost-benefit analysis of outsourcing versus in-house quality control is considered.

    Main Results:

    • Using hospital laboratories can significantly reduce costs associated with purchasing and maintaining specialized equipment.
    • Access to expert personnel within hospital labs enhances the quality-control process.
    • Validated testing in an external lab ensures accurate potency and compliance with compounding standards.

    Conclusions:

    • Hospital laboratories offer a viable and cost-effective solution for enhancing compounding pharmacy quality-control programs.
    • Validation of methods is crucial for ensuring the reliability of outsourced potency testing.
    • This approach supports pharmacies in meeting current compounding standards and delivering accurate preparations.