Comprehensive Quality Management System
DASHA is built on a robust quality foundation that ensures consistent delivery of products meeting global regulatory standards. Our GMP capabilities encompass a complete quality ecosystem designed to maintain the highest levels of compliance throughout the product lifecycle, providing a complete framework for the manufacture of high-quality pharmaceutical products and offering you confidence in both regulatory compliance and product performance throughout the global marketplace.
Manufacturing Excellence
- Purpose-Built Facilities: Clean room environments with appropriate classifications based on product requirements
- Validated Equipment: Qualification protocols for all manufacturing and utility systems
- Environmental Monitoring: Comprehensive program for particulate and microbial control
- Computer System Validation: 21 CFR Part 11 compliant electronic systems
- Process Validation: Three-stage approach including process qualification and continued verification
Quality Control Capabilities
- Fully Equipped QC Laboratory: State-of-the-art analytical instrumentation for raw material, in-process, and finished product testing
- Stability Program: ICH-compliant stability chambers with continuous monitoring
- Method Validation: Complete analytical method validation/verification per ICH guidelines
- Reference Standards Management: Properly characterized and stored reference materials
- Pharmacopeial Expertise: Testing capabilities aligned with USP, Ph. Eur., IP, and other major pharmacopoeias
Documentation and Compliance
- Electronic Quality Management System: Tracking of deviations, change controls, and CAPAs
- Batch Manufacturing Records: Comprehensive documentation from raw materials to final product
- Training Management: Qualification and periodic assessment of personnel competencies
- Audit Readiness: Prepared for inspections by regulatory agencies and client audits
- Annual Product Reviews: Systematic evaluation of process performance and product quality
Supply Chain Controls
- Supplier Qualification Program: Risk-based approach to vendor selection and monitoring
- Material Management: Segregated storage with appropriate environmental controls
- Sampling Plans: Statistically valid sampling procedures for incoming materials
- Certificate of Analysis Review: Verification of critical specifications before use
Continuous Improvement
- Quality Metrics Program: Tracking of key performance indicators to identify improvement opportunities
- Risk Management: Implementation of ICH Q9 principles throughout operations
- Knowledge Management: Systems to capture and leverage process understanding
- Technology Transfer: Structured approach to ensure seamless transition between development and commercial manufacturing