At Lolark Pharmaceuticals, quality is not just a commitment—it's the foundation of everything we do. Our rigorous quality systems ensure the highest standards of safety, efficacy, and reliability.
Our Quality Standards
We adhere to the most stringent international quality standards and regulatory requirements.
FDA Compliance
Full compliance with FDA regulations and Good Manufacturing Practices (GMP).
21 CFR Part 211ISO Certification
ISO 9001:2015 certified quality management systems across all facilities.
ISO 9001:2015Global Standards
Compliance with EMA, Health Canada, and other international regulatory bodies.
ICH GuidelinesComprehensive Quality Management
Our integrated quality management system encompasses every aspect of pharmaceutical development, manufacturing, and distribution to ensure consistent product quality and patient safety.
Risk-Based Approach
Proactive identification and mitigation of quality risks throughout the product lifecycle.
Continuous Improvement
Regular review and enhancement of processes based on data analysis and industry best practices.
Supplier Qualification
Rigorous qualification and ongoing monitoring of all suppliers and contract manufacturers.
Quality Performance
Our commitment to quality is reflected in our outstanding performance metrics.
Quality Assurance Processes
Multi-layered quality controls at every stage of development and manufacturing.
Raw Material Testing
Comprehensive testing of all incoming raw materials and components to ensure they meet our stringent specifications.
- • Identity and purity verification
- • Microbiological testing
- • Heavy metals analysis
- • Certificate of analysis review
In-Process Controls
Real-time monitoring and testing during manufacturing to ensure consistent product quality.
- • Process parameter monitoring
- • In-line quality checks
- • Statistical process control
- • Environmental monitoring
Finished Product Testing
Comprehensive testing of finished products before release to ensure safety and efficacy.
- • Potency and dissolution testing
- • Stability studies
- • Packaging integrity
- • Batch record review
Post-Market Surveillance
Ongoing monitoring of product quality and safety after market release.
- • Adverse event monitoring
- • Product complaint investigation
- • Market sample testing
- • Continuous risk assessment