Taj Pharma operates a WHO-GMP certified oral-solids facility in Sarigam, Gujarat. WHO-GMP certification is central to our export programme, underpinning acceptance of DEFRATAJ dossiers by WHO-PQ aligned national authorities across LATAM, Africa, Asia and CIS.
What WHO-GMP Means #
The World Health Organization's Good Manufacturing Practices (WHO-GMP) guidance specifies the minimum requirements for pharmaceutical production - from premises and equipment design, through documentation and quality systems, to product release and pharmacovigilance. WHO-GMP certification is issued by the national competent authority (in India, the respective State Food & Drug Administration) following on-site inspection against WHO-GMP requirements.
Scope of Our WHO-GMP Certification #
- Manufacturing, packaging and quality control of oral-solid dosage forms including tablets and dispersible tablets
- Covers the full DEFRATAJ product family (100, 125, 250, 400, 500 mg)
- Issued by the State FDA, renewed on periodic inspection
- Certificate of Pharmaceutical Product (CoPP) available on the WHO certification scheme format for each registered strength
Core Compliance Pillars #
| Pillar | Evidence |
|---|---|
| Pharmaceutical Quality System | Documented PQS; Site Quality Manual; SOPs; QA independence |
| Personnel | Qualified Person in place; documented training programmes; competency assessment |
| Premises & Equipment | Segregated suites; classified airlocks; qualified HVAC; IQ/OQ/PQ qualified equipment |
| Documentation | Version-controlled SOPs, batch records; electronic systems ALCOA+ compliant |
| Production | Validated processes; IPC monitoring; line clearance; deviation management |
| Quality Control | Independent QC laboratory; ICH Q2 validated methods |
| Outsourced Activities | Technical agreements with qualified suppliers |
| Complaints & Recall | Documented procedures; mock recall; pharmacovigilance interface |
| Self-Inspection | Annual programme; findings closed through CAPA |
WHO CoPP Availability #
A WHO-format Certificate of Pharmaceutical Product is available for each DEFRATAJ strength on request - typically required in export registration dossiers for countries aligned to the WHO certification scheme. CoPP issuance is coordinated by our regulatory affairs team.
Why It Matters to Importers & Ministries of Health #
WHO-GMP certification reassures procurement agencies that the manufacturer operates against an internationally recognised quality benchmark. Combined with our CTD-dossier readiness, it materially accelerates registration timelines and reduces assessment risk in WHO-PQ aligned markets.