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Why GLP Certification Matters for Global Compliance (part 7)

  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 ...

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. πŸ“₯ 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: πŸ”— https://dst....

Why GLP Certification Matters for Global Compliance (part 5)

  Why GLP Certification Matters for Global Compliance (part 5); Essential OECD Documents on Good Laboratory Practice (GLP): A Complete Reference Published by VISNOVA Consultancy – Guiding You Through Global GLP Standards For laboratories, regulators, and contract research organizations (CROs) involved in non-clinical health and environmental safety studies, the OECD Principles of Good Laboratory Practice (GLP) form the foundation of data credibility and international acceptance. To support consistent implementation and monitoring, the OECD has published a detailed series of guidance documents that clarify GLP principles and offer best practices across various aspects of laboratory operations. In this blog, we provide an overview of the key OECD GLP documents every GLP-compliant test facility should be familiar with. πŸ“˜ OECD Series on Principles of GLP and Compliance Monitoring Below is the official list of documents developed by the OECD Working Group on GLP , which are us...

Why GLP Certification Matters for Global Compliance (part 4)

  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). πŸ”‘ 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 che...

Why GLP Certification Matters for Global Compliance (part 3)

  Why GLP Certification Matters for Global Compliance (part 3); Scope and Extent of the National GLP Program: Enabling Reliable Safety Data for Global Markets Published by VISNOVA Consultancy – Regulatory Support for Quality-Driven Laboratories In today’s regulatory landscape, generating high-quality and internationally acceptable safety data is essential for industries working with chemicals, pharmaceuticals, and biologicals. The National Good Laboratory Practice (GLP) Program  in India, administered by the National GLP Compliance Monitoring Authority (NGCMA) , ensures that such data is generated under validated systems aligned with the OECD Principles of GLP . This blog explores the scope and extent of India’s National GLP Program—what it covers, who it benefits, and how it enables international acceptance of non-clinical safety data. 🌍 What Does the National GLP Program Cover? The Indian National GLP Program covers non-clinical health and environmental safety testin...

Why GLP Certification Matters for Global Compliance (part 2)

  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. πŸ”Ή 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 . πŸ”Ή 2. NGCMA Secretariat The operational arm of the programme, functioning under the administrative control of DST. The Head of NGCMA reports directly to the C...

Why GLP Certification Matters for Global Compliance (part 1)

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 Compli...