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Quality Assurance01:19

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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 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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Aligning actions are communicative strategies individuals employ to maintain social harmony and preserve personal identity in the face of potential disruptions to social norms. These actions are particularly important in managing social impressions when one's behavior might be seen as inappropriate, incompetent, or morally questionable.Types of Aligning ActionsThe three principal types of aligning actions are disclaimers, accounts, and apologies.DisclaimersDisclaimers are preventive; they are...
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The z-transform is a fundamental tool in digital signal processing, enabling the analysis of discrete-time systems through its various properties. It is an invaluable tool for analyzing discrete-time systems, offering a range of properties that simplify complex signal manipulations. One fundamental property is linearity. For any two discrete-time signals, the z-transform of their linear combination equals the same linear combination of their individual z-transforms. This property is essential...
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The cultivation of environmental microorganisms has long been hindered by the inability to replicate complex native conditions in vitro. The isolation chip (iChip) addresses this limitation by facilitating the growth of previously uncultivable microorganisms through in situ incubation. Designed for high-throughput microbial cultivation, the iChip comprises hundreds of microchambers, each capable of housing a single microbial cell. These microchambers are loaded with a mixture of molten agar and...
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Quantitative Optical Microscopy: Measurement of Cellular Biophysical Features with a Standard Optical Microscope
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Enabling ICH Q10 Implementation--Part 1. Striving for Excellence by Embracing ICH Q8 and ICH Q9.

Nuala Calnan1, Kevin O'Donnell, Anne Greene

  • 1School of Chemical and Pharmaceutical Science, Dublin Institute of Technology, Dublin, Ireland;

PDA Journal of Pharmaceutical Science and Technology
|November 23, 2013
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Summary

Pharmaceutical companies struggle to adopt International Conference on Harmonisation (ICH) Q10 guidelines for operational excellence. Embracing quality management systems and unlocking knowledge are key to improving medicine quality and reducing patient risk.

Keywords:
Continual improvementICH Q10 Pharmaceutical Quality System (PQS)ICH Q8 (R2) Product DevelopmentICH Q9 Quality Risk Management (QRM)ImplementationInnovationKnowledge creation and management.LeadershipLean manufacturingOperational excellenceRegional regulatory enforcementSenior and corporate management responsibilitiesSix sigmaThe International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

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Area of Science:

  • Pharmaceutical Quality Systems
  • Operational Excellence
  • Regulatory Compliance

Background:

  • The pharmaceutical industry has faced criticism for lagging manufacturing expertise compared to other sectors.
  • Despite the International Conference on Harmonisation (ICH) Q10 guideline's availability since 2008, widespread adoption of advanced Quality Management Systems (QMS) remains limited.
  • Many organizations have yet to fully transform traditional QMS, hindering progress in operational excellence.

Purpose of the Study:

  • To analyze the slow adoption of ICH Q10-based pharmaceutical quality systems (PQS).
  • To explore the reasons behind the limited implementation of operational excellence principles and quality management techniques in the pharmaceutical sector.
  • To propose strategies for enhancing the availability of high-quality medicines globally.

Main Methods:

  • Review of current pharmaceutical quality management practices.
  • Analysis of the gap between traditional QMS and ICH Q10 requirements.
  • Exploration of barriers to adopting quality management techniques like Six Sigma.

Main Results:

  • The transformation to ICH Q10-based PQS is progressing slowly, with only a few organizations fully embracing it.
  • A significant gap exists between desired operational excellence and current industry practices.
  • Limited adoption of quality management techniques hinders the consistent delivery of high-quality medicines.

Conclusions:

  • Achieving operational excellence requires a fundamental shift towards embodying PQS principles.
  • Unlocking scientific and tacit knowledge within organizations is crucial for progress.
  • Embracing ICH Q8(R2), Q9, and Q10 can lead to demonstrable improvements and potentially reduced regulatory oversight.