GLP Certification

Good Laboratory Practices (GLP) is a quality system for research laboratories to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical and non-clinical safety tests.

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What is GLP?

Good Laboratory Practice (GLP) is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical and non-clinical safety tests.

Benefits Explained

Data Acceptance

Ensures that data generated is acceptable to regulatory authorities worldwide (like FDA, EMA, OECD countries).

Credibility

Enhances the credibility and reputation of the laboratory's test results and study reports.

Regulatory Approval

Mandatory for submitting safety data for chemicals, pharmaceuticals, and agrochemicals for product registration.

Reduced Re-testing

Facilitates mutual acceptance of data (MAD) among countries, avoiding duplicative testing and saving costs.

Requirements for Certification

Quality Manual Defining GLP policies and organization structure
SOPs Standard Operating Procedures for all lab activities
Calibration Records Maintenance and calibration logs of equipment
Staff CVs Qualification and training records of personnel
Study Plans Protocols and reports of conducted studies

Certification Process

1

Application

Submit application to the National GLP Compliance Monitoring Authority (NGCMA).

2

Pre-Inspection

Initial assessment of the laboratory's readiness and documentation.

3

Final Inspection

Detailed on-site inspection by GLP inspectors to verify compliance.

4

Certification

Grant of GLP Compliance Certificate upon successful inspection.

Frequently Asked Questions

Why Choose India Certify?

We provide a dedicated Startup Advisor, monthly compliance status reports, and ensure 100% accurate filing at the lowest fees in the market.

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