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Patient Safety and Product Quality
Quality
Objective
Our objective is to build and sustain a dependable organization recognized for the quality of its products, integrity of its practices and competence of its people. Through management commitment and the collective responsibility of every employee, we strive to achieve consistent compliance, operational excellence, customer confidence and improved patient outcomes. This commitment reflects our enduring promise: 'Health First.'
- Recognized standards
- Demonstrated compliance
- Trusted across markets
Commitment
To achieve our quality objective, we integrate quality into every decision, process and activity. We are committed to maintaining regulatory compliance, applying scientific and risk-based controls, developing competent people and continually improving our products, processes and technologies. This commitment is supported by transparent practices, responsible operations and a shared culture in which quality is everyone's responsibility.
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Regulatory and GMP Compliance
03
Scientific and Risk-Based Decisions
04
Competent and Accountable People
05
Technology & Continuous Improvement
06
Integrity, Transparency & Responsibility
Quality Management System
Our Pharmaceutical Quality System translates this commitment into a structured and continually operating framework. It connects management oversight, trained personnel, controlled processes and reliable data across product development, technology transfer, sourcing, manufacturing, packaging, quality control, product release and post-market monitoring.
Through documented procedures, defined responsibilities, performance monitoring and continual improvement, the system ensures that quality risks are identified, controlled and reviewed throughout the product lifecycle.
Quality Governance & Management Review - Direction & Capability
- Purpose:
- Establish leadership accountability, quality direction and effective oversight.
- Works through:
- Quality policy, objectives, performance indicators, escalation and periodic management review.
- Delivers:
- Timely decisions, adequate resources and continual improvement of the quality system.
Quality Governance & Management Review - Direction & Capability
- Purpose:
- Establish leadership accountability, quality direction and effective oversight.
- Works through:
- Quality policy, objectives, performance indicators, escalation and periodic management review.
- Delivers:
- Timely decisions, adequate resources and continual improvement of the quality system.
Documentation Control and Data Integrity - Records & Traceability
- Purpose:
- Ensure controlled documents and reliable data throughout the product lifecycle.
- Works through:
- SOPs, change control, ALCOA+ principles, audit trails and periodic review.
- Delivers:
- Accurate records, traceability and confidence in batch documentation.
Training and Personnel Qualification - Competence & Accountability
- Purpose:
- Ensure personnel are qualified and competent for assigned GMP activities.
- Works through:
- Training programs, qualification assessments, role-based competency and refresher training.
- Delivers:
- Skilled workforce, reduced human error and consistent process execution.
Supplier and Material Management - Incoming Quality Assurance
- Purpose:
- Assure quality of materials and services from approved suppliers.
- Works through:
- Supplier qualification, material specifications, incoming inspection and vendor monitoring.
- Delivers:
- Approved sources, compliant materials and supply chain reliability.
Facility, Equipment and Process Validation - Qualified Operations
- Purpose:
- Demonstrate that facilities, equipment and processes consistently produce intended results.
- Works through:
- IQ/OQ/PQ, process validation, cleaning validation and periodic requalification.
- Delivers:
- Qualified assets, validated processes and sustained manufacturing capability.
Quality Risk Management - Risk-Based Decisions
- Purpose:
- Proactively identify, assess and control quality risks across the product lifecycle.
- Works through:
- Risk assessment tools, FMEA, periodic review and risk mitigation plans.
- Delivers:
- Prioritized controls, reduced failure modes and informed decision-making.
Deviation, Change Control and CAPA - Issue Resolution
- Purpose:
- Manage non-conformances, changes and corrective actions systematically.
- Works through:
- Deviation reporting, change control procedures, root cause analysis and effectiveness checks.
- Delivers:
- Closed loops on issues, controlled changes and prevention of recurrence.
Quality Control and Product Release - Testing & Disposition
- Purpose:
- Verify product quality and authorize release only when specifications are met.
- Works through:
- Sampling plans, analytical testing, stability data review and batch disposition.
- Delivers:
- Compliant products, reliable release decisions and patient safety assurance.
Stability Monitoring and Product Quality Review - Lifecycle Oversight
- Purpose:
- Monitor product quality over shelf life and review overall quality performance.
- Works through:
- Stability studies, annual product quality review and trend analysis.
- Delivers:
- Confirmed shelf life, ongoing compliance and continuous product improvement.
Audits, Complaints, Recall & Continual Improvement - System Enhancement
- Purpose:
- Evaluate system effectiveness and respond to quality events with sustained improvement.
- Works through:
- Internal and external audits, complaint handling, recall readiness and improvement initiatives.
- Delivers:
- Audit readiness, effective market response and a stronger quality culture.