Why GLP Certification Matters for Global Compliance (part 7)

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Why GLP Certification Matters for Global Compliance (part 7)

Understanding the Procedures of NGCMA Secretariat: A Guide for GLP-Driven Test Facilities

By Visnova Consultancy
Empowering Test Facilities Across India with GLP Excellence

India’s global leadership in non-clinical safety data generation is anchored in the National GLP Compliance Monitoring Authority (NGCMA) — a robust framework established under the Department of Science and Technology (DST), Government of India. For Contract Research Organizations (CROs), test facilities (TFs), and regulatory professionals, understanding NGCMA procedures is essential for ensuring compliance, certification, and international data acceptance under OECD’s Mutual Acceptance of Data (MAD) system.

This blog post presents a comprehensive yet simplified walkthrough of the roles, responsibilities, and procedures of the NGCMA Secretariat, including GLP inspections, application reviews, certification, surveillance, and re-certification protocols.

🔍 Role of NGCMA Secretariat

The NGCMA Secretariat is responsible for:

  • Implementing the National GLP Programme.

  • Laying down policies and aligning India’s GLP practices with OECD GLP Principles.

  • Managing GLP applications, inspections, certifications, and international collaborations.

  • Training and empanelling GLP Inspectors.

  • Promoting GLP awareness via seminars and capacity-building workshops.

📥 Application for GLP Certification: Step-by-Step

  1. Submission
    Applications are accepted year-round via the NGCMA portal along with a prescribed fee.

  2. Acknowledgement & ID
    Upon successful submission, the system generates a unique ID (DST/GLP-(APP)-xyz/yy) for all future correspondence.

  3. Preliminary Review
    Designated officers evaluate the application for completeness, including:

    • TF legal status and scope

    • GLP area of expertise

    • SOP adequacy and QAU functioning

    • Regulatory approvals (e.g., CPCSEA, IBSC)

    • Master schedule and floor plans

    • Declaration by TFM

  4. Follow-up Action
    If the application is incomplete, TFs must submit additional documents. Ineligible applications are closed (fees non-refundable).

  5. Inspection Planning
    Upon acceptance, an inspection team is constituted and inspection dates are scheduled.

🔍 Types of GLP Inspections

1. Pre-Inspection

  • Duration: 1–2 days

  • Purpose: Assess GLP readiness

  • Outcome: Observations are shared and TF must submit an Action Taken Report (ATR) within 6 months.

2. Final Inspection

  • Conducted after a satisfactory ATR.

  • Duration: 2–3 days

  • Involves review of SOPs, equipment logs, study records, raw data, QA audits, etc.

3. Surveillance Inspection

  • Conducted at 18 months ± 3 months after certification.

  • Focuses on ongoing GLP compliance.

  • TF must submit ATR within 45 days.

4. Re-certification Inspection

  • Conducted every 3 years.

  • Duration: 2–5 days

  • Similar in scope to final inspection.

5. Extension of Scope

  • TFs can apply for expanded certification after 3 months of GLP approval or with surveillance.

6. Verification Inspection

  • Conducted to confirm implementation of corrective actions after deviations or non-compliance.

7. Joint/Regulatory-Requested Inspection

  • Requested by Indian/Foreign Regulatory Authorities or OECD GLP CMAs.

  • Follows standard NGCMA inspection protocol.

8. Surprise Inspection

  • Conducted without notice when:

    • There’s suspicion of data falsification or non-compliance.

    • Structural or organizational changes occur without intimation.

    • Feedback from foreign agencies suggests serious lapses.

🧑‍🔬 GLP Inspectors and Confidentiality

NGCMA trains and empanels inspectors as per GLP-107. Inspectors must sign confidentiality and impartiality declarations (GLP-106). All inspections are conducted in alignment with strict ethical and procedural guidelines.

🗂️ GLP Certificate Issuance

Post-final inspection, and upon recommendation by the Technical Committee and approval by the Chairman, Head, NGCMA issues the GLP certificate. The certificate includes:

  • Name and address of the TF

  • Scope of expertise

  • Type of test items and test systems

  • Validity (3 years)

🌐 International Collaboration and Compliance

NGCMA actively collaborates with the OECD Working Party on GLP. Non-compliance alerts (domestic or foreign) are shared with relevant authorities. The Secretariat also submits an Annual Overview of applications and compliance status to the OECD.

🎓 GLP Awareness and Capacity Building

In partnership with Quality Council of India (QCI), NGCMA conducts:

  • Workshops, seminars, and training program across India.

  • Special events on request from academia, industry, and professional bodies.

  • Funding support based on approved proposals and post-event reporting.

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