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Designing a structure involves a series of considerations, primarily the material's ultimate strength, calculated through tests that measure changes under increased force until the material reaches its breaking point or limit. The ultimate load, where the material breaks, is divided by its original cross-sectional area, resulting in the ultimate normal stress or strength. The ultimate shearing stress is another significant factor taken into account.
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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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In designing structural elements and machine parts using ductile materials, it is crucial to ensure that these components withstand applied stresses without yielding. Yielding is initially determined through a tensile test, which evaluates the material's response to uniaxial stress. However, tensile stress is insufficient when components face biaxial or plane stress conditions This condition requires advanced criteria to predict failure.
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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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Considerations in Qualifying Critical Suppliers.

Amy Summers1

  • 1Restore Health Consulting LLC, Laguna Beach, California. info@restorehealthconsulting.com.

International Journal of Pharmaceutical Compounding
|December 15, 2023
PubMed
Summary

New United States Pharmacopeia (USP) standards require compounders to source active pharmaceutical ingredients and excipients from FDA-registered facilities. Pharmacies must now implement robust supplier qualification processes to ensure quality and compliance.

Area of Science:

  • Pharmaceutical Compounding
  • Regulatory Compliance
  • Quality Assurance

Background:

  • Upcoming United States Pharmacopeia (USP) <797> and <795> revisions mandate sourcing from FDA-registered facilities for active pharmaceutical ingredients (APIs) and excipients.
  • The U.S. Food and Drug Administration (FDA) advises compounders to vet their bulk API and excipient suppliers.
  • Regulatory bodies are increasingly requiring 503A compounding pharmacies to demonstrate supplier qualification processes, mirroring requirements for 503B outsourcing facilities.

Purpose of the Study:

  • To guide pharmacies in establishing and implementing effective supplier qualification programs.
  • To ensure that critical supplies and services meet quality and compliance specifications.
  • To prepare compounders for evolving regulatory expectations regarding supplier oversight.

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Main Methods:

  • Review of impending USP <797> and <795> guidelines.
  • Analysis of FDA recommendations for supplier knowledge.
  • Discussion of quality assurance principles applied to supplier qualification.
  • Examination of regulatory and accrediting body expectations for 503A compounders.

Main Results:

  • Pharmacies need to proactively develop and integrate supplier qualification into their quality assurance frameworks.
  • Understanding and vetting suppliers is crucial for compliance with new USP standards.
  • Demonstrating a systematic approach to supplier qualification is becoming a standard expectation.

Conclusions:

  • Implementing a comprehensive supplier qualification program is essential for pharmacies to meet new regulatory demands.
  • Proactive supplier management enhances the quality and safety of compounded medications.
  • Adopting these practices ensures compliance and strengthens the overall quality assurance program.