Quality Policy

Uncompromising Quality & Compliance

Adhering strictly to WHO-GMP standards, international Pharmacopoeia monographs, and computerized data integrity guidelines.

Accreditations

Certifications & Global Standards

Independently audited and certified by leading pharmaceutical regulatory bodies.

WHO Standard

WHO-GMP

Good Manufacturing Practices Certification for Oral Solids & Liquids

Current Validated Status

QMS Accreditation

ISO 9001:2015

Quality Management System Certification

System Certified

Environmental

ISO 14001:2015

Environmental Management & Zero Liquid Discharge System

Green Campus Compliant

Laboratory Standard

GLP Certified

Good Laboratory Practices for Analytical & QC Testing

Validated QC Laboratories

Quality Architecture

Quality Assurance & Control Infrastructure

Documentation & SOPs

Comprehensive Standard Operating Procedures (SOPs), Master Batch Records (MBR), and logbooks ensuring zero ambiguity.

Validation & CSV

Validation of manufacturing processes, cleaning procedures, HVAC systems, and 21 CFR Part 11 Computerized Systems.

Batch Traceability

100% end-to-end batch tracking from raw material supplier CoA to final secondary cartoning barcode.

Continuous Improvement

CAPA (Corrective and Preventive Actions) root cause analysis, internal audit cycles, and annual product quality reviews (APQR).

Quality Infrastructure

Advanced Analytical Testing Laboratories

State-of-the-art laboratory instrumentation ensuring batch purity, dissolution, and microbiological safety.

HPLC & Chemical Assay

Waters & Shimadzu Empower HPLC systems for precise assay, dissolution, and impurity profile testing.

Microbiology & Endotoxin Lab

Sterility testing suites, bio-burden assessment, and LAL bacterial endotoxin testing for parenterals.

Quality Assurance & Audit Readiness

Continuous internal audit cycles, CAPA tracking, and automated 21 CFR Part 11 electronic batch release.