Taj Pharma's manufacturing processes are designed in line with the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009). While formal PIC/S inspection is an authority-to-authority matter, our alignment with PIC/S principles supports export into PIC/S member-state markets and facilitates harmonised quality dialogue with international regulators.
About PIC/S #
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an international instrument that co-ordinates GMP inspection among over 50 national regulatory authorities. Its GMP guide (PE 009) is closely aligned with EU GMP (EudraLex Volume 4) and is used as the quality benchmark in many ministries of health and tender agencies.
Where We Align with PIC/S Principles #
| Area | Alignment |
|---|---|
| Pharmaceutical Quality System | ICH Q10-based PQS with documented quality objectives, management review and continuous improvement |
| Personnel | Qualified Person accountability; documented training and competency programme |
| Premises & Equipment | Purpose-built facility with segregated suites; qualified HVAC and utilities |
| Documentation | Version-controlled documentation hierarchy; ALCOA+ data integrity |
| Production | Validated processes with ICH Q8/Q9/Q10 lifecycle approach; IPC and line clearance |
| Quality Control | Independent QC with ICH Q2 validated methods; robust OOS procedures |
| Annexes | Alignment with relevant Annexes (e.g. Annex 1 principles for sterile where applicable; Annex 9 for liquids/creams where applicable) |
| Recall & Complaints | Documented procedures and mock-recall programme |
What PIC/S Alignment Delivers for DEFRATAJ #
- Dossiers formatted and justified in a way that fits PIC/S member assessment expectations
- Quality system language and documentation familiar to PIC/S-trained regulatory reviewers
- Simplified technical dialogue with customer quality teams used to European / PIC/S frameworks
- Supports customer-led audits carried out to PIC/S-style checklists
Continuous Improvement #
The quality team tracks updates to PIC/S guides (including Annex revisions) and integrates relevant changes into internal SOPs via formal Change Control - ensuring that our GMP posture remains current with the international benchmark rather than drifting over time.
Customer Audits #
Distributor and tender partners can arrange on-site quality audits of the Sarigam facility under CDA. Audit scope typically covers the PIC/S GMP framework plus any customer-specific quality-agreement items.