Quality & HSE Policy

Quality Policy

Commitment to Clinical Precision, Regulatory Excellence & ISO-Driven Continuous Improvement

At Aptine Medicine Supply, quality is not a department—it is the foundation of every operational decision, procurement protocol, and service promise. We recognize that our responsibility as a pharmaceutical supplier directly impacts public health outcomes. Therefore, our quality assurance framework is governed by both a ground-level understanding of market dynamics and a top-tier commitment to international standards.

Policy Commitment

This policy is issued under the authority of the Board of Directors and Executive Management, who remain actively engaged in its implementation, monitoring, and continuous improvement. We are working toward full ISO 9001:2015 certification, and all operational units are expected to align with this objective.

Our Quality Commitments:

1. Regulatory-Conformant Procurement

We procure exclusively from certified manufacturers and wholesalers with proven regulatory standing (including MCAZ, UK MHRA, WHO PQ, and Indian FDA). Each batch is accompanied by full documentation, COAs, and product origin confirmation.

2. Inventory Accuracy and Stock Integrity

All medicines are received, stored, and dispatched under controlled conditions. This includes temperature-sensitive handling, FEFO inventory management, and automated alerts for approaching expiry. Manual records are reinforced with system audits and verification.

3. Storage & Distribution Infrastructure

Whether through a leased pharmacy or stand-alone facility, we commit to operating only in premises that meet MCAZ-specified layout, security, sanitation, and environmental controls. All sites undergo periodic quality audits conducted by our Technical Manager and independent inspectors.

4. Technical Oversight and Batch Traceability

The Technical Manager serves as the responsible person for pharmaceutical compliance. Each batch can be traced to source and distribution, with the full paper trail available for client, regulatory, and internal audits.

5. Training & Capacity Building

All staff handling pharmaceutical stock receive structured induction and refresher training in GDP, product identification, risk handling, and documentation. Training plans are reviewed and updated quarterly.

6. Non-Conformance and Recall Protocols

We maintain a fully documented SOP for managing product complaints, non-conformances, and recalls. The recall process includes immediate internal action, client notification, and regulatory escalation as necessary.

7. Client & Stakeholder Feedback Integration

Quality reviews incorporate structured feedback from clients, pharmacists, and distributors. This feedback is actioned through Quality Improvement Plans (QIPs) and fed into quarterly review meetings.

Health, Safety & Environmental (HSE) Policy

Structured for Protection, Compliance, and Sustainable Practices Across Our Supply Chain Our HSE Policy reflects our dedication to the safety of our team, the communities we serve, and the environment in which we operate. Whether receiving bulk stock from abroad or distributing medication to clinics and pharmacies across Zimbabwe, we commit to minimising risk, preventing harm, and promoting responsible handling of medical products.

Policy Commitment

This policy is driven by executive leadership and endorsed by the Board. We are in the preparatory stages of aligning with ISO 45001:2018 for Occupational Health and Safety and ISO 14001:2015 for Environmental Management, ensuring that our practices reflect global standards in HSE governance.

Our HSE Principles:

1. Regulatory-Conformant Procurement

We procure exclusively from certified manufacturers and wholesalers with proven regulatory standing (including MCAZ, UK MHRA, WHO PQ, and Indian FDA). Each batch is accompanied by full documentation, COAs, and product origin confirmation.

2. Pharmaceutical Waste & Expiry Management

All team members involved in receiving, unpacking, storing, and dispatching medicines are trained in safe material handling, PPE usage, and product risk classification. Handling guidelines are posted visibly at each worksite.

3. Incident Reporting and Risk Response

A zero-tolerance policy exists for unreported incidents. Any safety or environmental risk is logged immediately, and root cause analysis is performed by the Technical Manager. Lessons learned are shared across the team.

4. Facility Safety & Emergency Planning

Distribution and storage locations are equipped with basic fire safety measures, ventilation, emergency exits, and incident management protocols. All premises must pass periodic safety audits.

5. Environmental Impact Minimisation

We strive to reduce packaging waste, promote recycled materials, and avoid unnecessary emissions through efficient delivery scheduling and minimal physical print-outs (where possible).

6. Staff Well-being and Safety Culture

HSE is part of induction for every employee. Safety briefings are conducted monthly, and an open-door policy exists for employees to raise safety or environmental concerns without fear of reprisal.

7. Third-Party Alignment

We ensure that all logistics partners and third-party storage or distribution contractors are equally aligned with our HSE standards, and we require documented HSE protocols before formal engagement.