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Related Concept Videos

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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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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Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

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The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
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Testing Water Quality01:14

Testing Water Quality

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When the quality of water for concrete preparation is uncertain, its impact on the setting time of cement and compressive strength of mortar is assessed by comparison with de-ionized or distilled water benchmarks. American Society for Testing and Materials (ASTM) C1602 requires the setting times to be within 90 minutes of the control, British Standard (BS) 3146:1980 allows a 30-minute variance in the initial setting, while British Standards European Norm (BS EN) 1008 specifies initial setting...
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Testing a Claim about Standard Deviation01:19

Testing a Claim about Standard Deviation

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A complete procedure to test a claim about population standard deviation or population variance is explained here.
The hypothesis testing for the claim of population standard deviation (or variance) requires the data and samples to be random and unbiased. The population distribution also must be normal. There is no specific requirement on the sample size as the estimation is based on the chi-square distribution.
As a first step, the hypothesis (null and alternative) concerning the claim about...
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Data Validation01:15

Data Validation

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Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:
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Benchmarking the Vendor Qualification Process.

Kenneth Getz1, Michael Wilkinson2, Jay Turpen3

  • 1Tufts Center for the Study of Drug Development, Tufts University School of Medicine, 75 Kneeland Street, 11th Floor, Boston, MA, 02111, USA. Kenneth.getz@tufts.edu.

Therapeutic Innovation & Regulatory Science
|December 1, 2020
PubMed
Summary
This summary is machine-generated.

Vendor qualification assessments are time-intensive, with single-service providers taking 5 months and multi-service providers taking 7 months. Contract research organizations (CROs) complete these assessments faster, using fewer personnel.

Keywords:
OutsourcingProcurementVendor evaluationVendor qualification

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Area of Science:

  • Pharmaceutical development
  • Biotechnology
  • Contract research

Background:

  • Vendor qualification assessment (VQA) is crucial but lacks quantitative benchmarks.
  • Existing perceptions suggest VQA is costly and time-consuming.

Purpose of the Study:

  • To quantitatively characterize and benchmark the vendor qualification assessment process.
  • To gather baseline data on the time and resources invested in VQA.

Main Methods:

  • Survey conducted by Tufts Center for the Study of Drug Development (Tufts CSDD) in collaboration with the Avoca Group.
  • Data collected from 120 unique pharmaceutical, biotechnology, and contract research organizations.
  • Analysis of vendor qualification and re-qualification cycle times and resource allocation.

Main Results:

  • Average VQA cycle times: nearly 5 months for single-service providers, nearly 7 months for multi-service providers.
  • Re-qualification cycle times are only marginally faster than initial qualifications.
  • Significant variations observed based on company size, type, and use of customized assessment areas.
  • Contract research organizations (CROs) demonstrate significantly faster VQA processes with fewer personnel.

Conclusions:

  • Companies invest substantial time and resources in a high volume of vendor qualifications and re-qualifications annually.
  • VQA process efficiency varies significantly across different company types and sizes.
  • CROs offer a more streamlined approach to vendor qualification assessments.