Quality Assurance
Our quality assurance system implements proactive measures designed to prevent quality issues before they occur, ensuring products consistently meet all specifications.
At Sovvaka Global, we believe that quality must be built into products from the beginning. Our comprehensive quality assurance approach focuses on prevention rather than detection, ensuring consistent quality across all our operations.
Quality Assurance Activities
Our quality assurance system encompasses a range of activities designed to prevent quality issues and ensure consistent product quality.
Documentation Control
Comprehensive system for creating, reviewing, approving, and managing quality-related documentation to ensure accuracy and accessibility.
Training & Qualification
Structured programs to ensure all personnel have the necessary knowledge, skills, and competencies to perform their roles effectively.
Supplier Quality Management
Rigorous processes for qualifying, monitoring, and managing suppliers to ensure the quality of incoming materials and services.
Internal Audits
Regular, systematic evaluations of processes, systems, and facilities to verify compliance with procedures and identify improvement opportunities.
Deviation Management
Structured approach to identifying, documenting, investigating, and resolving deviations from established procedures or specifications.
Change Control
Controlled process for evaluating, approving, and implementing changes to ensure they do not adversely affect product quality.
Comprehensive Validation Activities
Validation is a critical component of our quality assurance system, providing documented evidence that processes, systems, and equipment consistently perform as intended.
Process Validation
Systematic approach to establishing documented evidence that a process consistently produces results meeting predetermined specifications and quality attributes.
Equipment Qualification
Documented verification that equipment is properly installed, operates correctly, and produces the expected results consistently.
Analytical Method Validation
Confirmation through laboratory studies that analytical methods are suitable for their intended use and provide reliable results.
Computer System Validation
Documented evidence that computer systems are fit for their intended use, operate as expected, and maintain data integrity.
Corrective and Preventive Action (CAPA) System
Our robust CAPA system is a cornerstone of our quality assurance approach, driving continuous improvement and preventing recurrence of quality issues.
Identification
01Systematic identification of actual or potential quality issues from various sources, including audits, complaints, and deviations.
Investigation
02Thorough investigation to determine the root cause of identified issues using appropriate methodologies like 5-Why or Fishbone analysis.
Risk Assessment
03Evaluation of the potential impact of the issue on product quality, patient safety, and regulatory compliance to prioritize actions.
Action Planning
04Development of specific corrective actions to address the immediate issue and preventive actions to prevent recurrence.
Implementation
05Execution of approved corrective and preventive actions with clear responsibilities, timelines, and deliverables.
Effectiveness Verification
06Systematic verification that implemented actions have effectively addressed the issue and prevented recurrence.
Benefits of Our Quality Assurance System
Our comprehensive quality assurance system provides numerous benefits to our organization, partners, and customers.
Prevention of Quality Issues
Proactive approach that prevents quality issues rather than detecting them after they occur, reducing waste and rework.
Consistent Product Quality
Ensures products consistently meet all specifications and quality requirements, building customer trust and satisfaction.
Regulatory Compliance
Facilitates compliance with regulatory requirements across multiple markets, reducing compliance risks.
Cost Reduction
Reduces costs associated with quality failures, investigations, and remediation through prevention-focused approaches.
Continuous Improvement
Drives ongoing improvement of processes and systems through systematic identification and resolution of issues.
Enhanced Reputation
Builds and maintains a reputation for quality and reliability in the marketplace, strengthening customer relationships.
Learn More About Our Quality Assurance
Contact our quality team to learn more about our quality assurance system and how it ensures the highest standards for pharmaceutical products.
Our Quality Assurance Expertise
- GMP-compliant quality systems
- Risk-based quality assurance
- Validation expertise
- Supplier quality management
- Continuous improvement methodologies