Why GLP Certification Matters for Global Compliance (part 3)

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 Why GLP Certification Matters for Global Compliance (part 3);

Scope and Extent of the National GLP Program: Enabling Reliable Safety Data for Global Markets

Published by VISNOVA Consultancy – Regulatory Support for Quality-Driven Laboratories

In today’s regulatory landscape, generating high-quality and internationally acceptable safety data is essential for industries working with chemicals, pharmaceuticals, and biologicals. The National Good Laboratory Practice (GLP) Program in India, administered by the National GLP Compliance Monitoring Authority (NGCMA), ensures that such data is generated under validated systems aligned with the OECD Principles of GLP.

This blog explores the scope and extent of India’s National GLP Program—what it covers, who it benefits, and how it enables international acceptance of non-clinical safety data.

🌍 What Does the National GLP Program Cover?

The Indian National GLP Program covers non-clinical health and environmental safety testing across a wide range of product types. These include:

✅ Covered Test Items:

  • Agrochemicals

  • Cell Lines

  • Cosmetic Products

  • Feed Additives

  • Food Additives

  • Industrial Chemicals

  • Medical Devices (limited to biocompatibility studies; excludes batch release testing)

  • Human Pharmaceuticals

  • Veterinary Pharmaceuticals

  • Viruses

These test items are typically synthetic chemicals, but may also include herbal extracts, biological substances, and occasionally living organisms, depending on the regulatory context.

🎯 Objective of GLP-Compliant Testing

The main goal is to generate non-clinical safety data that provides critical insights into the chemical, biological, or toxicological properties of the test items with respect to:

  • Human health

  • Environmental safety

This data supports regulatory submissions, risk assessments, and product approvals in India and internationally—particularly in OECD and MAD-adherent countries.

🧪 Scope of Testing Environments

The GLP Programme supports testing in multiple controlled settings, including:

  • Laboratory studies

  • Greenhouse studies

  • Field studies

These diverse environments allow for realistic simulation of how chemicals or biologics behave under various conditions, enhancing the credibility of the data produced.

🧠 Areas of Expertise Eligible for GLP Certification

Test Facilities (TFs) with expertise in the following domains may apply to NGCMA for GLP Certification:

✔️ Recognized Areas:

  • Physical-Chemical Testing

  • Toxicity Studies

  • Mutagenicity Studies

  • Environmental Toxicity Studies (aquatic and terrestrial organisms)

  • Behavior in Water, Soil, Air, and Bio-accumulation Studies

  • Residue Studies

  • Effects on Mesocosms and Natural Ecosystems

  • Analytical and Clinical Chemistry Testing

  • Other Specialized Studies (subject to review and specification)

This structured approach ensures consistency, transparency, and high scientific standards across Indian test facilities—making their data globally credible.

🌐 Why It Matters: Global Trust through Indian Science

By adhering to OECD norms and focusing on comprehensive safety evaluation, the Indian GLP Program:

  • Enables regulatory acceptance in 42+ countries

  • Enhances data integrity and reproducibility

  • Reduces the need for duplicative studies abroad

  • Promotes cost-effective global expansion for Indian industry and CROs

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