Pharmaceutical Quality System

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Pharmaceutical Quality System in International
Conference on Harmonization (ICH) Q10
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• The purpose for which the International
  Conference on Harmonization (ICH) has issued
  wide-ranging in ICH Q 10 guidelines is that they
  help individuals and organizations in the
  pharmaceutical industry avoid duplication of
  their work, especially in pharmaceutical research
  and product registration.

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Reduction of double work is the important purpose

• Putting in place greater harmonization in the
  area of pharmaceutical product registration by
  interpreting and applying technical ICH
  guidelines was the aim with which the ICH was
  launched in 1990.

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• The harmonization the ICH Q 10 aims to bring
  about seeks to reduce and possibly eliminate
  repetition of testing and reduce double work of
  research and development of new human medicines.
• It uses extensive guidelines to achieve this.
  These guidelines are given for all areas of ICH Q
  10.

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Quality Guidelines

• Related to the Quality area these guidelines
  include crucial milestones such as doing
  stability studies, defining appropriate limits
  for impurities testing, and evolving a malleable
  approach to GMP risk management based
  pharmaceutical quality.

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Safety Guidelines

• Relates to the safety aspect of carrying out
  research in the carcinogenic, genotoxic and repro
  toxic areas, which carry a high risk of danger.

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Efficacy Guidelines

• To ensure efficacy in research, ICH guidelines
  cover areas such as the conduct, design, safety
  and reporting of clinical trials.
• Efficacy guidelines also include biotechnological
  processes and pharmacogenetics or genomics
  techniques, which are aimed at producing
  medicines that target disease better.

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Multidisciplinary Guidelines

• These are guidelines are for areas left out of
  the Quality, Safety and Efficacy Guidelines. Core
  elements of this area of ICH Q 10 guidelines
• Include ICH medical terminology (MedDRA), the
  Common Technical Document (CTD) and the
  development of Electronic Standards for the
  Transfer of Regulatory Information (ESTRI).

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