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Quality Assurance & Compliance
At Prosem Healthcare, quality is at the core of every medicine we manufacture. We adhere strictly to national and international regulatory guidelines, deploying sophisticated analytical testing, GMP-certified workflows, and rigorous batch control to deliver safe, effective, and reliable pharmaceutical formulations.
GMP Compliance
Strict implementation of Good Manufacturing Practices across all sterile and non-sterile production blocks.
WHO Benchmarks
Standardized raw material validation, environmental monitoring, and modern microbiological assay controls.
Batch Traceability
End-to-end barcoding and documentation from active pharmaceutical ingredients (APIs) to primary packaging.
Stability Testing
Extensive accelerated and long-term shelf-life testing according to ICH climatic zone parameters.
Our Regulatory Certifications
Verified documentation and third-party manufacturing standard compliances.
WHO-GMP Certification
Certified for Good Manufacturing Practices by authorized regulatory bodies, ensuring pharmaceutical excellence from formulation to distribution.
- Cleanroom HVAC Air Handling
- Zero Cross-Contamination Design
ISO 9001:2015
Recognized Quality Management System (QMS) guaranteeing continuous process improvement, customer satisfaction, and risk-based assessment.
- Standardized SOP Adherence
- Periodic Vendor Auditing
Good Laboratory Practices (GLP)
Equipped with calibrated HPLC, dissolution testers, and spectrophotometers ensuring precision in assay analysis and microbiological sterility.
- Raw Material & Excipient Testing
- Finished Product Release Testing
DCGI & State FDA Approved
All manufacturing licenses and pharmaceutical formulas are thoroughly vetted and registered under state and central drug control standards.
- Approved Drug Schedules
- Compliant Labeling & Packaging
Multi-Stage Quality Control Protocol
Raw Material Quarantine
Every active compound and excipient undergoes chemical validation before batch formulation.
In-Process Quality Check
Weight variation, hardness, disintegration, and uniform mixing checks during compression/filling.
Finished Goods Assurance
Sealing integrity tests (Alu-Alu/Blister packs), batch coding verification, and release clearance.
Looking for Third-Party Manufacturing or PCD Franchise?
Partner with a quality-first pharmaceutical manufacturer with transparent documentation and certifications.