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Essential elements of quality control.

J C Boylan

    American Journal of Hospital Pharmacy
    |November 1, 1983
    PubMed
    Summary
    This summary is machine-generated.

    Hospital pharmacies must implement robust quality control systems, mirroring pharmaceutical industry standards, to ensure the sterility and safety of compounded injectable products. This involves detailed procedures and documentation for consistent, high-quality patient care.

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    Area of Science:

    • Pharmaceutical Sciences
    • Healthcare Quality Management
    • Hospital Pharmacy Practice

    Background:

    • The pharmaceutical industry adheres to Current Good Manufacturing Practices (CGMP) mandated by the U.S. Food and Drug Administration (FDA).
    • CGMP requires documented procedures for ensuring the sterility and nonpyrogenicity of injectable drug products.
    • While FDA specifies outcomes, pharmaceutical manufacturers develop diverse quality control (QC) systems.

    Purpose of the Study:

    • To discuss the essential components of pharmaceutical industry quality control.
    • To apply these quality control principles to hospital pharmacy admixture services.
    • To emphasize the necessity of hospital-specific quality control systems for compounded medications.

    Main Methods:

    • Review of quality control system components used in the pharmaceutical industry.

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  • Analysis of FDA's Current Good Manufacturing Practices requirements.
  • Adaptation of industrial quality control techniques for hospital pharmacy settings.

    • Main Results:

    • Pharmaceutical industry QC systems typically include master formulas, manufacturing instructions, packaging instructions, and batch records.
    • Key QC documents comprise specifications, test methods, and sampling procedures.
    • Hospital admixture services require similar comprehensive QC programs to prevent and correct deficiencies.

    Conclusions:

    • Hospital pharmacy admixture services must establish their own quality control systems.
    • These systems are crucial for protecting the integrity of drug products during compounding.
    • Adopting industry best practices enhances patient safety and medication quality in hospitals.