WHO GMP Compliance

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✔Our in-house team handles over 50 types of business licenses.
✔We provide end-to-end services across India.
✔Ensuring smooth and continuous adherence to all legal requirements.

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Benefits of WHO GMP Compliance

✔Global Market Acceptance and International Credibility
✔Compliance with International Regulatory Norms for Exports
✔Improved Product Quality and Safety Throughout Production
✔Boosts Business Reputation Among Buyers and Stakeholders
✔Supports Licensing, Tender Eligibility, and Government Contracts

Applicability

WHO GMP Compliance is required for:

✔Pharmaceutical manufacturers seeking export certification
✔Drug and cosmetic production units requiring GMP compliance
✔Companies applying for government healthcare tenders
✔Manufacturers expanding into international markets
✔Existing units upgrading quality systems to WHO-GMP standards

Certification Process

Initial Assessment

Evaluation of current manufacturing practices and facility readiness.

Gap Analysis & Documentation

Identification of gaps in SOPs, records, and quality systems with corrective guidance.

Facility Audit & Process Review

Internal audit to prepare for inspection by competent authority.

Application Submission

Submission to State Drug Authority or CDSCO (if applicable) for certification.

GMP Inspection

Inspection by government officials to verify WHO-GMP compliance.

Certification Issued

Upon successful inspection, WHO-GMP Certificate is granted.

Documents Required

✔Company profile
✔List of equipment and machinery
✔Manufacturing site layout
✔Standard Operating Procedures (SOPs)
✔Quality control and assurance protocols
✔Details of production staff and their qualifications
✔Batch manufacturing and distribution records
✔Validation protocols and records
✔Product testing and stability data
✔Regulatory licenses (Drug License, FSSAI, etc.)

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