Why GLP Certification Matters for Global Compliance (part 2)

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Why GLP Certification Matters for Global Compliance (part 2);

Organizational Structure and Nature of the National GLP Program.

By VISNOVA Consultancy – Empowering Laboratories for Global Recognition

The National GLP Compliance Monitoring Authority (NGCMA), under the Department of Science & Technology (DST), Government of India, is the apex body that administers the National Good Laboratory Practice (GLP) Programme in accordance with OECD guidelines. The programme ensures that non-clinical safety data from India is reliable and globally acceptable.

🔹 1. GLP Authority (Apex Body)

  • The highest policy-making and regulatory oversight body for the Indian GLP programme.

  • Constituted via Gazette Notification dated August 31, 2002.

  • Provides strategic direction and ensures alignment with OECD GLP Principles.

🔹 2. NGCMA Secretariat

The operational arm of the programme, functioning under the administrative control of DST. The Head of NGCMA reports directly to the Chairman, GLP Authority.

Key Responsibilities of the NGCMA Secretariat:

  • Develops and implements policies in line with OECD and national regulations.

  • Maintains international cooperation with the OECD Working Party on GLP.

  • Coordinates with GLP Test Facilities (TFs) and processes certification applications.

  • Organises inspections and study audits in India and abroad.

  • Trains and appoints qualified GLP Inspectors and Technical Experts.

  • Issues GLP compliance certificates and maintains compliance records.

  • Takes corrective or adverse action in cases of serious non-compliance.

  • Conducts GLP awareness and training programmes across India.

  • Maintains inspection data and supports the formation of technical working groups.

📜 Nature of the National GLP Programme

The Indian GLP Programme is voluntary, yet highly strategic for test facilities aiming for regulatory acceptance in global markets.

Key Features:

  • Eligibility: Any test facility (TF) in India conducting non-clinical health or environmental safety studies for regulatory submission can apply for GLP certification.

  • Validity: GLP Certification is valid for 3 years. Surveillance inspections are conducted mid-term to ensure ongoing compliance with OECD Principles of GLP and Test Guidelines.

  • Certified TF List: NGCMA maintains a public list of GLP-certified test facilities.

  • International Cooperation:

    • NGCMA collaborates with Regulatory Authorities (RAs) and Compliance Monitoring Authorities (CMAs) of OECD member and non-member MAD adherent countries.

    • Facilitates joint inspections and study audits upon request, enabling mutual regulatory trust and data acceptance.

    • Indian RAs have reciprocal access for inspections in other MAD-compliant countries.

  • Compliance Enforcement:

    • NGCMA can take adverse decisions against non-compliant TFs, potentially affecting the validity of their data.

    • Such actions are governed by Document GLP-113: “Policies and procedures of NGCMA for taking adverse and other decisions against test facilities.”

🌍 Empowering Global Data Acceptance

India's robust GLP framework, through NGCMA, empowers domestic laboratories and CROs to confidently pursue regulatory submissions across 42 MAD-adherent countries, saving costs and elevating India’s global scientific reputation.

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