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

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

218
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...
218
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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

209
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,...
209
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

389
Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
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Introduction to Quality Control in a Compounding Pharmacy.

Loyd V Allen1

  • 1International Journal of Pharmaceutical Compounding, Edmond, Oklahoma. lallen@ijpc.com.

International Journal of Pharmaceutical Compounding
|March 25, 2017
PubMed
Summary

A robust quality program is essential for compounding pharmacies to guarantee accurate and stable drug preparations. This includes quality control, quality assurance, and continuous improvement strategies.

Area of Science:

  • Pharmaceutical Sciences
  • Pharmacy Practice

Background:

  • Compounding pharmacies require stringent quality measures to ensure patient safety and therapeutic efficacy.
  • Ensuring the stability and proper compounding of pharmaceutical preparations is a critical aspect of pharmacy practice.

Purpose of the Study:

  • To outline the essential components of a comprehensive quality program for compounding pharmacies.
  • To discuss the integration of quality control, quality assurance, and continuous quality improvement.

Main Methods:

  • Review of quality management principles in pharmaceutical compounding.
  • Description of in-house (in-pharmacy) quality program elements.
  • Evaluation of the role of external laboratories in quality assurance.

Main Results:

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  • A multi-faceted quality program encompassing various strategies is necessary.
  • Both internal pharmacy procedures and external laboratory testing contribute to overall quality.

Conclusions:

  • Implementing a thorough quality program is fundamental for compounding pharmacy operations.
  • Continuous quality improvement is key to maintaining high standards in pharmaceutical compounding.