Why GLP Certification Matters for Global Compliance (part 1)

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Ensuring Safety through Science: Why GLP Certification Matters for Global Compliance

Published by VISNOVA Consultancy – Trusted Partner in Regulatory Readiness

Many countries across the globe require that manufacturers of industrial chemicals, pharmaceuticals (human and veterinary), agrochemicals, cosmetic products, food/feed additives, and medical devices prove that their products are safe for human health and the environment.

This proof comes in the form of scientifically valid non-clinical safety studies, which are scrutinized by regulatory bodies before product approval and marketing.

To standardize such testing, the Organization for Economic Co-operation and Development (OECD) developed the internationally recognized system of Good Laboratory Practice (GLP).

India’s Commitment: NGCMA and Global Data Acceptance

In recognition of the importance of GLP, the Government of India established the National GLP Compliance Monitoring Authority (NGCMA) under the Department of Science & Technology (DST) on April 24, 2002.

A major milestone was achieved when India became a full adherent to OECD’s Mutual Acceptance of Data (MAD) on March 3, 2011. This global endorsement offers tangible benefits to Indian industry:

✅ Key Benefits of OECD MAD for Indian Stakeholders:

  • Regulatory Acceptance Abroad:
    Non-clinical data generated by GLP-certified Indian Test Facilities (TFs) is accepted by regulatory authorities in all 36 OECD member countries and 6 non-member MAD adherent countries, including major markets like the USA, EU, UK, Japan, and Australia.
  • Cost-Efficiency:
    Indian companies no longer need to outsource safety studies to overseas GLP-certified labs, thereby saving significant testing costs.
  • Global Business Expansion:
    Indian GLP-certified Test Facilities and Contract Research Organisations (CROs) are now positioned as credible global service providers, leading to increased international collaborations and revenue opportunities.

📝 Voluntary but Strategic: The GLP Certification Process

Although GLP certification is voluntary, it is increasingly becoming strategic for industries aiming at regulated markets. Facilities that perform non-clinical safety studies on the following product types can apply:

  • Industrial chemicals
  • Human & veterinary pharmaceuticals
  • Agrochemicals
  • Food & feed additives
  • Cosmetic products
  • Medical devices

🔍 How GLP Certification Works in India

NGCMA oversees the entire certification process, ensuring that facilities operate according to OECD GLP Principles:

1.     Application Submission – In prescribed format with applicable fee

2.     Pre-Inspection – Evaluation of infrastructure and documentation

3.     Final Inspection – Detailed assessment of GLP compliance

4.     Technical Committee Review – Recommendation for certification

5.     Certification Approval – Final decision by Chairman, GLP Authority

Validity: 3 years
Surveillance Inspection: At 18 months
Re-certification Inspection: In the third year

🧪 Scope of Certification

GLP certification can be obtained in one or more of the following areas of expertise:

  • Physical-Chemical Testing
  • Toxicity and Mutagenicity Studies
  • Environmental Fate & Behaviour (soil, air, water)
  • Bioaccumulation & Residue Studies
  • Analytical & Clinical Chemistry
  • Environmental Toxicity (aquatic & terrestrial)
  • Studies on Mesocosms & Ecosystems
  • Custom safety testing based on test item and guideline

🌐 Why GLP Certification Matters for Indian Businesses

  • ✈️ Global Market Access
  • 💸 Reduced Regulatory Testing Costs
  • 📈 Growth in CRO Services and Exports
  • 🔍 Better QA/QC Systems and Traceability
  • 🧬 Enhanced Scientific Credibility

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