Why GLP Certification Matters for Global Compliance (part 6)

-

 Why GLP Certification Matters for Global Compliance (part 6);

Comprehensive Guide to GLP Certification Under NGCMA: Application, Inspection & Compliance

Published by VISNOVA Consultancy – Supporting India's Scientific Excellence in GLP

For Indian laboratories and contract research organizations (CROs) aiming for international credibility, obtaining Good Laboratory Practice (GLP) certification under the National GLP Compliance Monitoring Authority (NGCMA) is essential. The process ensures that non-clinical safety data is generated with the highest standards of integrity, traceability, and global acceptability.

This blog provides an in-depth summary of the application process, inspection protocol, compliance responsibilities, and fee structure under India’s GLP Program.

📥 How to Apply for GLP Certification

All applications—whether for initial certification, re-certification, or extension of scope—must be submitted through the official NGCMA portal:
🔗 https://dst.gov.in/ngcma

✔️ Eligibility Criteria

Test Facilities (TFs) eligible for GLP certification include:

  • CROs and R&D labs

  • Academic institutions (Universities, Institutes of National Importance)

  • Government or PSU labs

  • Private industries and test divisions of organizations

Note: GLP certification applies only to the specific division or unit performing GLP studies, not the entire organization.

📄 Documentation & Mandatory Submissions

  • Declaration of adherence to OECD GLP Principles

  • Master Schedule including details of GLP and non-GLP studies

  • SOPs for all operational aspects

  • Archive policies (must retain data for at least 3 certification cycles)

  • Declaration of computerized systems and their validation

  • Clear identification of TF location with floor plans

  • Records of at least one completed and archived study per claimed scope

  • At least one ongoing GLP study with a live phase at the time of inspection

🔍 Types of Inspections by NGCMA

NGCMA conducts various inspections under GLP-104 and GLP-111, including:

🧪 Standard Inspections:

  • Pre-Inspection

  • Final Inspection

  • Surveillance (typically at 18 ± 3 months)

  • Re-certification Inspection

🛡️ Special Inspections:

  • Extension-in-scope inspections

  • Verification inspections

  • Surprise inspections (with Chairman’s approval)

  • Inspections on request by foreign Regulatory Authorities (RAs) or GLP Monitoring Authorities (CMAs)

  • Joint inspections with OECD-member/non-member MAD-adherent countries

Findings from all inspections are shared with the TF, and applicable authorities if required.

📃 Action on Deviations

In case of non-compliance, NGCMA may:

  • Issue a statement on GLP validity concerns

  • Recommend study rejection to RAs

  • Suspend or withdraw GLP certification

  • Notify international GLP CMAs

  • Require public disclaimer to be added to study reports

  • Take legal action, if warranted

🎯 Corrective Action Protocol

TFs must submit an Action Taken Report (ATR) within:

  • 45 days for most inspections

  • 6 months for pre-inspections

Supporting documents, including photos or evidence of SOP updates, must be included.

🏢 Maintaining & Modifying GLP Certification

📆 Validity: 3 Years

The GLP certificate remains valid for 3 years subject to annual compliance and fees.

💳 Fees:

CategoryAmount (INR)
Application Fee (per expertise)₹30,000 (Non-refundable)
Annual Certification Fee (ACF)₹30,000/year
Certificate Modification₹15,000
Travel & Accommodation of InspectorsActuals (arranged via QCI)

Note: QCI arranges travel and stay; TF bears cost via reimbursement.

🛠️ Extension / Reduction in Scope

  • Extension: ₹30,000 per new area; ₹15,000 for minor modifications

  • Reduction:

    • Voluntary: On TF request

    • Forced: If no GLP studies are done in an area for over a year

Revised certificates will have suffixes like GLP-XXXA/YYYY.

🔁 Voluntary Withdrawal

TFs may exit the program by written notice. Requirements include:

  • Reason for withdrawal

  • Updated master schedule

  • Archive location declaration

NGCMA will inform OECD and may inspect archived data if needed.

📢 Grievance, Appeals & Legal Jurisdiction

  • Complaints and appeals must follow the procedure in GLP-108

  • Unresolved matters fall under New Delhi court jurisdiction only


Comments

Post a Comment

Popular posts from this blog

Organization Process

-
Understanding the Organizational Process in a GLP-Compliant Lab In the context of Good Laboratory Practice (GLP) and Contract Research Organizations (CROs), the term "organizational process" holds significant weight. It is the foundation on which reliable, reproducible, and regulatory-compliant research is built. But what exactly does it mean? 📌 Definition : The organizational process refers to the structured system of planning, executing, monitoring, and documenting all activities within a laboratory or research setting to ensure studies meet their scientific and regulatory objectives. 🔍 Why Is It Important in GLP-CROs? In GLP environments, data integrity and accountability are non-negotiable. The organizational process ensures: ✅ Each study is pre-approved and methodically designed ✅ Roles and responsibilities are well-defined ✅ Resources are efficiently allocated ✅ Every step is documented, reviewed, and auditable 🔄 Key Components of the Organizational Process Step Wha...
Read more

What Are Complex Generics?

-
  What Are Complex Generics? The New Frontier in Affordable Innovation – By VISNOVA Consultancy In today’s pharmaceutical industry, complex generics are redefining the boundaries of generic drug development. These specialised formulations are bioequivalent to branded drugs but involve far greater technical sophistication , requiring advanced capabilities in formulation science, device integration, and regulatory compliance. 🧬 What Makes a Generic ‘Complex’? Unlike conventional generics, complex generics are harder to develop due to unique routes of administration, formulation technologies, or embedded delivery devices. Key Feature Examples Non-oral routes Inhalers, injectables, transdermal patches Complex formulation Liposomes, nanoparticle suspensions Drug-device combinations Auto-injectors, metered-dose inhalers (MDIs) Extended/controlled release Once-weekly injections, slow-release tablets Site-specific delivery Ocular, nasal, pulmonary, transdermal drugs Difficult bioe...
Read more

GLP-CRO labs

-
Introduction Good Laboratory Practice (GLP) is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported. For pharmacy students aspiring to enter the pharmaceutical industry, especially in Contract Research Organizations (CROs), understanding GLP is crucial. What is a CRO? Contract Research Organizations (CROs) are independent organizations that provide support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. CROs play a key role in analytical method development, validation, and GLP-compliant studies. The Role of GLP in Analytical Labs GLP ensures the integrity and reliability of data generated by analytical labs. Key elements include: Standard Operating Procedures (SOPs) Documentation and traceability Equipment qualification and calibra...
Read more