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Related Concept Videos

Quality Control01:05

Quality Control

1.1K
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...
1.1K
Quality Assurance01:19

Quality Assurance

860
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...
860
Introduction to Statistical Process Control01:15

Introduction to Statistical Process Control

497
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...
497
Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

142
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...
142
Interpreting R Charts01:22

Interpreting R Charts

243
R chart, or range chart, is a fundamental tool in statistical process control used to monitor the variability within a process. It complements the X-bar (x̄) chart by focusing on the range of the data, rather than individual values, providing a clear picture of the process dispersion over time.
An R chart plots the range of subsets of measurements collected from a process. Each point on the chart represents the range—defined as the difference between the maximum and minimum...
243
Equivalence: In Vitro and In Vivo Bioequivalence01:17

Equivalence: In Vitro and In Vivo Bioequivalence

122
Body:Bioequivalence studies are crucial in evaluating whether new drugs can match an approved one regarding pharmacological effects and clinical performance. These studies test if drugs, despite different dosage forms, share identical plasma concentration-time profiles. Three types of equivalence are central to these studies: chemical, pharmaceutical, and therapeutic. Chemical equivalence indicates that two or more drug products contain identical active ingredients in equal amounts.
122

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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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ISO 9001:2015 Versus ICH Q10 - A Comparison.

Carsten Aaberg1, Heribert Dahmen2, Cledwyn Davies3

  • 1Novo Nordisk A/S, Novo Alle 1, DK-2880 Bagsvaerd, Denmark.

PDA Journal of Pharmaceutical Science and Technology
|October 1, 2020
PubMed
Summary

The 2015 revision of ISO 9001 (International Organization for Standardization 9001) did not necessitate a revision of the ICH Q10 guideline. ICH Q10 continues to align with ISO 9001 principles for pharmaceutical quality systems.

Keywords:
ICHISO 9001:2015Pharmaceutical quality systemQ10 Quality GuidelineQuality management system

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Area of Science:

  • Pharmaceutical Quality Systems
  • Regulatory Science
  • Quality Management Systems

Background:

  • ICH Q10, established in 2008, provides a model for pharmaceutical quality systems (PQS) aligned with ISO 9001 principles.
  • It integrates Good Manufacturing Practice (GMP) and complements ICH Q8 and Q9 guidelines.
  • ISO 9001:2008 provided the foundational quality management system (QMS) structure for ICH Q10.

Purpose of the Study:

  • To assess if the significant changes in ISO 9001:2015 warrant a revision of the ICH Q10 guideline.
  • To determine if ICH Q10 remains compliant with the updated ISO 9001 principles.
  • To evaluate the continued relevance of ICH Q10 as a pharmaceutical quality management system model.

Main Methods:

  • Comparative analysis of ISO 9001:2008 and ISO 9001:2015 standards.
  • Evaluation of ICH Q10 against the principles and structure of the revised ISO 9001:2015.
  • Assessment of the impact of ISO 9001:2015 changes on pharmaceutical quality system requirements.

Main Results:

  • The core principles and structure of ICH Q10 remain consistent with ISO 9001:2015.
  • No fundamental conflicts were identified between ICH Q10 and the revised ISO 9001 standard.
  • The changes in ISO 9001:2015 do not invalidate the existing framework of ICH Q10.

Conclusions:

  • ICH Q10 does not require revision due to the ISO 9001:2015 update.
  • ICH Q10 continues to effectively represent a harmonized model for pharmaceutical quality management systems.
  • The guideline remains a valid framework for implementing PQS throughout the product lifecycle.