ICH | ISO

Difference Between ICH and ISO Guidelines

Byipharmacist July 11, 2023September 11, 2024

Elaboration

ICH stands for: International conference on harmonization of technical requirements for registration of pharmaceuticals for human use.
ISO stands for: International oraganization for standardization.

Focus

ICH primarily focused on pharmaceutical and biopharmaceutical industry.
ISO cover broad range of industries including medicinal, food, and others.

Development

ICH developed through the collaboration of regulatory authorities and pharmaceutical industries.
ISO developed through the technical committees.

Scope

ICH concentrates on technical and scientific aspects of pharmaceutical product development and registration.
ISO covers various management system, processes, and requirements.

Applicability

Often mandatory for regulatory compliance in countries participating in ICH.
ISO can be adopted voluntary by organizations.

Harmonization

ICH romote global harmonization of technical requirements for pharmaceuticals.
ISO may vary across countries due to national adoption.

Read also: Overview of the ICH Guidelines

Audit | VS

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Guidelines | ICH

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Regulatory Affairs

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Qualification | Validation

Difference Between Calibration, Validation and Qualification

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Regulatory Affairs | VS

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Difference between Process and Procedure in Quality Management

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