WHO GMP Compliance
WHO-GMP (Good Manufacturing Practices) is a system that ensures products are consistently produced and controlled according to quality standards set by the World Health Organization. These practices apply to the manufacturing, processing, packaging, and storage of pharmaceutical products, medical devices, cosmetics, food, and dietary supplements.
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Benefits
Global Market Acceptance
Enhances product credibility and opens doors to international markets.Compliance with International Norms
Fulfills regulatory requirements for exports, especially in countries recognizing WHO-GMP.Improved Product Quality & Safety
Ensures consistent quality control throughout production.Boosts Business Reputation
Increases trust among buyers, regulators, and stakeholders.Supports Licensing & Tender Eligibility
Required for government contracts, public tenders, and large-scale buyers.
🛠️ Process of Registration
Initial Assessment
Evaluation of current manufacturing practices and facility readiness.Gap Analysis & Documentation
Identification of gaps in SOPs, records, and quality systems; guidance on corrective actions.Facility Audit & Process Review
Internal audit to prepare for inspection by competent authority.Application Submission
Submit application to the 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 & 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.)
What You’ll Get
Expert Team with Regulatory Experience
Facility Audit & Documentation Support
Assistance in Facing GMP Inspection
Customized SOPs & Quality Control Systems
PAN India Service Coverage
Quick Turnaround with End-to-End Support
Frequently Asked Questions
Manufacturers of pharmaceuticals, medical devices, cosmetics, and nutraceuticals looking to export or improve product credibility.
Yes, in many countries, WHO-GMP compliance is mandatory to import pharmaceutical and health-related products.
Typically 30 to 90 days, depending on the readiness of your facility and documentation.
Usually valid for 3 years, subject to periodic inspections.
Absolutely. We draft and customize SOPs tailored to your manufacturing process.
What clients say
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