Quality Management
Our comprehensive quality management system provides the framework for all quality activities, ensuring consistent implementation of quality principles across our operations.
At Sovvaka Global, we've developed a robust quality management system that integrates international standards with industry best practices to deliver pharmaceutical products of the highest quality.
Quality Management System Components
Our quality management system consists of several integrated components that work together to ensure comprehensive quality oversight.
Quality Policy & Objectives
Clear quality policy and measurable objectives that guide our quality activities and align with our organizational strategy.
Organizational Structure
Well-defined roles, responsibilities, and reporting relationships that ensure effective quality management.
Process Management
Systematic approach to defining, controlling, and improving processes that impact product quality.
Performance Monitoring
Comprehensive metrics and key performance indicators to measure and improve quality system effectiveness.
Continuous Improvement
Structured approach to identifying opportunities for improvement and implementing effective changes.
Documentation System
Controlled documentation that ensures consistent implementation of procedures and maintains knowledge.
Risk-Based Quality Management
We implement a risk-based approach to quality management, focusing resources on areas that have the greatest impact on product quality and patient safety.
Risk Assessment
Systematic identification and evaluation of factors that could affect product quality, using tools like FMEA, HACCP, and risk ranking.
Risk Control
Implementation of measures to reduce or eliminate identified risks, with controls proportionate to the level of risk.
Risk Review
Ongoing evaluation of risk control measures to ensure continued effectiveness and to identify new or changing risks.
Risk Communication
Clear communication about risks and control measures to all relevant stakeholders, ensuring shared understanding.
Management Review Process
Our regular management review process ensures ongoing oversight and continuous improvement of our quality management system.
Data Collection & Analysis
01Comprehensive gathering and analysis of quality data from various sources, including audits, customer feedback, and performance metrics.
Review Meeting
02Structured meeting with senior management to review quality system performance, identify trends, and make strategic decisions.
Action Planning
03Development of specific action plans to address identified issues, implement improvements, and allocate necessary resources.
Implementation
04Execution of approved action plans with clear responsibilities, timelines, and deliverables.
Follow-up & Verification
05Monitoring of action plan implementation and verification of effectiveness through appropriate measures.
Documentation
06Comprehensive documentation of the review process, decisions, actions, and outcomes for regulatory compliance and knowledge management.
Benefits of Our Quality Management System
Our robust quality management system provides numerous benefits to our organization, partners, and customers.
Consistent Product Quality
Ensures consistent delivery of high-quality products that meet all specifications and customer expectations.
Regulatory Compliance
Facilitates compliance with regulatory requirements across multiple markets and jurisdictions.
Operational Efficiency
Streamlines processes and reduces waste, leading to improved operational efficiency and cost savings.
Risk Mitigation
Proactively identifies and addresses potential quality risks before they impact products or patients.
Continuous Improvement
Provides a framework for ongoing improvement of processes, products, and the quality system itself.
Knowledge Management
Captures and preserves organizational knowledge through effective documentation and training systems.
Learn More About Our Quality Management
Contact our quality team to learn more about our quality management system and how it ensures the highest standards for pharmaceutical products.
Our Quality Certifications
- ISO 9001:2015 Certification
- WHO GMP Compliance
- ICH Q10 Implementation
- PIC/S Standards Adherence
- Regional Regulatory Compliance