Quality & Compliance Standards
Uncompromising quality at every step — from sourcing and manufacturing to packaging and distribution.
Quality Policy
At SPPL, quality is a fundamental responsibility and a core element of our corporate philosophy. We are committed to developing, manufacturing, and supplying pharmaceutical products that consistently meet the highest standards of safety, efficacy, and regulatory compliance.
Our comprehensive Pharmaceutical Quality Management System (PQMS), aligned with current Good Manufacturing Practices (cGMP) and applicable national and international regulatory requirements, ensures robust oversight across procurement, manufacturing, testing, storage, and distribution.
We foster a culture of quality through continuous improvement, risk management, data integrity, and strict adherence to regulatory standards. Through disciplined execution and accountability at every level of the organization, we safeguard product quality and protect patient health worldwide.
Our Certifications
We maintain certifications from all major global pharmaceutical regulatory bodies.
EU-GMP
European Union Good Manufacturing Practice compliance
US-FDA
United States Food and Drug Administration approved
PIC/S
Pharmaceutical Inspection Co-operation Scheme
PMDA
Japan's Pharmaceuticals and Medical Devices Agency
TMDA
Tanzania Medicines and Medical Devices Authority
WHO-GMP
World Health Organization Good Manufacturing Practice certification
GMP
Good Manufacturing Practice standards
FSSAI
India's Food Safety and Standards Authority
ISO
International Organization for Standardization certifications
Supplier Qualification Process
Our rigorous 5-step qualification process ensures we partner only with the best manufacturers.
Facility Evaluation
Comprehensive audit of manufacturing facility infrastructure, equipment, and processes
Documentation Review
Assessment of SOPs, batch records, validation protocols, and quality agreements
GMP Compliance Check
Verification of certifications and compliance history
Sample Testing
Independent laboratory analysis of product samples for identity, potency, and purity
Ongoing Monitoring
Continuous supplier performance monitoring with regular re-qualification audits
Patient Safety Commitment
We implement blockchain-enabled traceability systems and comprehensive pharmacovigilance programs to ensure every medication can be tracked from manufacturer to patient, providing complete transparency and accountability.
Blockchain Traceability
Complete track-and-trace for every batch
Pharmacovigilance
Systematic monitoring of drug safety
Batch Testing
100% quality testing before release