Quality Policy

1. Our Commitment

OXYPharma is committed to supplying safe, effective, and compliant products that meet or exceed customer expectations and applicable regulatory requirements.

2. Scope

This policy applies to all operations that affect product quality and customer experience, including sourcing, manufacturing, packaging, storage, distribution, and support.

3. Quality Principles

• Compliance with all applicable laws and standards (e.g., GMP, GDP, ISO where relevant).
• Science-based decisions and documented evidence.
• Risk management to prevent defects and mitigate issues.
• Continuous improvement through measurable objectives and reviews.
• Customer focus and transparent communication.

4. Objectives (reviewed annually)

• On-time, in-full order fulfillment ≥ [target]%.
• Product defect rate ≤ [target]%.
• Customer satisfaction score ≥ [target].
• Closure of corrective actions (CAPA) within [X] days.

5. Responsibilities

• Top Management: Provide leadership, resources, and oversight of the Quality Management System (QMS).
• Quality Unit (QA/QC): Own the QMS; approve/reject materials and products; manage deviations, complaints, recalls, and CAPA.
• All Employees: Follow approved procedures, report issues, and support continuous improvement.

6. Product Quality & Safety

• Source materials only from qualified suppliers.
• Maintain documented specifications, test methods, and acceptance criteria.
• Ensure traceability from raw material to finished product lot.

7. GMP/GDP & Documentation

• Operate under written SOPs; use controlled records and forms.
• Changes follow formal change control; only approved documents are in use.
• Keep complete batch records and distribution logs.

8. Training & Competence

• Train personnel for their roles; maintain training records.
• Re-train when procedures or regulations change.

9. Supplier & Partner Management

• Qualify and periodically audit critical suppliers and service providers.
• Use quality agreements that define responsibilities and standards.

10. Complaints, Deviations, CAPA

• Log and investigate all complaints and deviations promptly.
• Implement corrective and preventive actions with effectiveness checks.

11. Returns & Recalls

• Handle returns per written procedure to prevent mix-ups or re-sale of unsuitable goods.
• Maintain a tested recall procedure to rapidly remove affected lots.

12. Storage & Distribution

• Store and ship under defined conditions to preserve product quality.
• Monitor temperature-sensitive goods where applicable.

13. Continuous Improvement

• Analyze KPIs, audit findings, and customer feedback.
• Conduct management reviews at least annually; set new quality goals.

14. Communication

• Share this policy internally and publish it on the website.
• Inform customers promptly about quality issues that may affect them.

15. Approval

This policy is approved by OXYPharma management and is effective on the date above.

Contact: support@oxypharma.com