Why GLP Certification Matters for Global Compliance (part 4)

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 Why GLP Certification Matters for Global Compliance (part 4);

Salient Features of GLP Certification & How to Get Certified in India

Published by VISNOVA Consultancy – Your Partner in GLP Compliance

In the world of scientific research and regulatory submissions, data credibility is everything. The Good Laboratory Practice (GLP) Certification, under India’s National GLP Programme, ensures that safety data produced by test facilities (TFs) meets internationally harmonised standards set by the Organisation for Economic Co-operation and Development (OECD).

This blog highlights the 7 key features of GLP certification and outlines the certification process for test facilities seeking recognition under the National GLP Compliance Monitoring Authority (NGCMA).

🔑 Salient Features of GLP Certification in India

1. A Structured National Compliance System

With the launch of the National GLP Programme, India now has a robust system to assess compliance of TFs involved in chemical testing as per OECD GLP Principles and Test Guidelines. This elevates India’s capability to meet international regulatory expectations.

2. Harmonised, Cost-Effective Testing Framework

GLP certification addresses the long-standing need of Indian laboratories to have a globally accepted, harmonised framework for chemical safety testing. It reduces duplication, lowers testing costs, and promotes trade and economic cooperation.

3. Reliable Data for Risk Assessment

For regulatory authorities (RAs) and policy makers, GLP serves as a scientific assurance tool. It provides confidence in the reliability of safety data used to make risk or hazard assessments for chemicals and their products. It also lays the foundation for future regulatory control measures.

4. Recognition of Indian Test Facility Capabilities

GLP certification allows Indian TFs to demonstrate that they possess the technical competence and systems aligned with international GLP standards. This enhances their credibility and appeal in global scientific collaborations.

5. Mutual Acceptance of Data (MAD) Advantage

As India is a full adherent to the OECD MAD system, data generated by GLP-certified Indian TFs is accepted in 42 countries (OECD and MAD-adherent nations). This eliminates the need for re-testing abroad and speeds up international regulatory approvals.

6. Cross-Border Collaboration & Inspections

GLP certification promotes information exchange and enables joint inspections or study audits with regulatory bodies from other OECD countries. This enhances transparency, mutual trust, and compliance assurance.

7. International Commitment via OECD Council Acts

Through the MAD agreement, NGCMA has pledged allegiance to the OECD’s Environmental Health and Safety Division and its Council Acts. This makes India a committed partner in maintaining global scientific integrity.

📋 How to Apply for GLP Certification in India

If your test facility is planning to conduct non-clinical health or environmental safety studies and wants to market products in India or abroad, here’s how the certification process works:

📝 1. Submit Application

Apply for:

  • GLP Certification

  • Re-Certification

  • Extension in Scope

All applications are submitted via the NGCMA portal along with the prescribed fee. Applications for extension must be made at least 3 months after certification or during surveillance inspection.

🔍 2. Application Review by NGCMA

NGCMA reviews your application based on:

  • Eligibility criteria

  • Completeness

  • Alignment with Document GLP-104 (Procedures of NGCMA Secretariat)

If eligible, an inspection team is formed and dates are communicated to the applicant. If the TF is not agreeable to the proposed dates/team, justified rescheduling is allowed.

⚠️ If eligibility is not met, the application will be closed and the fee is non-refundable.

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