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Related Concept Videos

Quality Control01:05

Quality Control

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...
Quality Assurance01:19

Quality Assurance

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...
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

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...
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
Introduction to Statistical Process Control01:15

Introduction to Statistical Process Control

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...
Production of Pharmaceuticals01:30

Production of Pharmaceuticals

Industrial insulin production uses genetically engineered E. coli expressing a proinsulin gene controlled by a tryptophan promoter and containing a methionine linker for later cleavage. The cells also carry ampicillin resistance for selective growth. Seed cultures are stored at −80 °C and production begins by thawing a small amount to inoculate starter cultures, which are progressively scaled to a 50,000-L bioreactor. In the bioreactor, E. coli grow in nutrient-rich media under sterile, tightly...

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Quality-control: from record keeping to key performance indicators: manging quality in compounding pharmacies.

Glaucia Karime Braga1, Maria Jose Viera Fonseca

  • 1Faculty of Pharmaceutical Sciences of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto, SaoPaulo, Brazil.

International Journal of Pharmaceutical Compounding
|August 23, 2013
PubMed
Summary

Compounding pharmacies need to analyze records, not just keep them, for continuous improvement. This study introduces nonfinancial key performance indicators for quality management in compounding pharmacies.

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Area of Science:

  • Pharmaceutical Compounding Quality Management
  • Quality Assurance in Pharmacy Practice

Background:

  • Record-keeping is essential for quality management systems in compounding pharmacies, adhering to Good Compounding Practices.
  • Current practices often focus on recording data without sufficient analysis, hindering continuous improvement.
  • Effective quality management requires more than just data collection; it necessitates data-driven insights.

Purpose of the Study:

  • To propose nonfinancial key performance indicators (KPIs) for compounding pharmacies.
  • To facilitate the development of organizational procedures for measuring product and service quality.
  • To introduce a new paradigm for quality management in compounding pharmacy settings.

Main Methods:

  • The article suggests the implementation of easily adoptable, nonfinancial key performance indicators.
  • Focus is placed on developing organizational procedures for quality measurement.
  • The approach emphasizes data analysis for continuous improvement.

Main Results:

  • Nonfinancial KPIs can be readily integrated into existing quality management systems.
  • Implementation of these indicators supports the development of robust quality measurement procedures.
  • This facilitates a shift towards a more analytical and improvement-focused approach.

Conclusions:

  • Analyzing recorded data through nonfinancial KPIs is crucial for enhancing compounding pharmacy services and products.
  • The proposed indicators offer a practical framework for pharmacies to measure and improve quality.
  • Adopting this new paradigm can lead to significant advancements in overall quality management within compounding pharmacies.