who develop ISO

The pharmaceutical industry, as one of the most sensitive sectors of healthcare, requires strict adherence to standards that guarantee the safety, quality, and efficacy of medicines. International ISO standards play a key role in establishing global harmonization and improving the processes of drug production, distribution, and monitoring. But an important question remains: Who develops these standards, and how do they address the specific needs of the pharmaceutical industry?

The International Organization for Standardization (ISO): The Main Body for Standards Development

The International Organization for Standardization (ISO) is an independent, non-governmental organization comprised of representatives from over 160 countries. ISO’s primary mission is to develop global standards to facilitate trade, enhance safety, and improve quality across all industries, including pharmaceuticals.

ISO Technical Committees: The Heart of Pharmaceutical Standards Development

ISO standards are developed by specialized Technical Committees (TCs), which consist of international experts from academia, industry, and regulatory bodies. In the pharmaceutical field, some of the most important committees include:

ISO/TC 215 (Health Informatics): Focuses on standardizing health information systems, including pharmaceutical data management and medical product tracking.
ISO/TC 212 (Clinical Laboratory Testing and In Vitro Diagnostic Test Systems): Develops standards for the quality of laboratory equipment and diagnostic methods related to pharmaceuticals.
ISO/TC 176 (Quality Management): Develops standards such as ISO 9001, which form the basis of quality management systems in drug manufacturing.
ISO/TC 194 (Biological and Clinical Evaluation of Medical Devices): Establishes criteria for the safety and performance of equipment used in drug production and testing.

These committees collaborate with esteemed organizations like the World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to update and adapt the standards.

The Standards Development Process: From Idea to Implementation

Identifying a Need: Industries, governments, or research institutions identify the need for a new standard.
Forming a Working Group: International experts draft the standard.
Public Consultation: The draft is circulated for feedback among ISO members and stakeholders.
Final Approval: After revisions, the standard is published based on member consensus.

Key ISO Standards in Pharmaceuticals

ISO 9001: Quality management system for ensuring drug manufacturing processes.
ISO 13485: Quality management standard for medical devices and related materials.
ISO 15378: Specific requirements for primary packaging materials for medicines.
ISO/IEC 17025: Competence requirements for testing and calibration laboratories, critical for quality control labs.

Why are ISO Standards Critical for the Pharmaceutical Industry?