+251969111144 info@berhanpharma.com.et Serving hospitals, laboratories, universities and research institutions across Ethiopia

Quality and governance are part of Berhan Pharma's corporate identity.

The website highlights quality, governance, and controlled-system themes that support institutional confidence and documentation readiness.

Current Contact
info@berhanpharma.com.et
+251969111144
Governance Overview

Institutional trust is strengthened by visible policies, standards alignment, and controlled-system themes.

Berhan Pharma's governance positioning brings together policy documents, standards-oriented language, and a documented operational-control model relevant to regulated supply environments.

This page is intended as an executive overview. It helps institutional reviewers understand the control environment without replacing detailed controlled documents.
EFDA Directive No. 872/2022 and GDP/GSP-aligned distribution controls
ISO 13485:2016 quality-system alignment for medical-device environments
ISO 14971:2019 risk-management alignment
ISO 9001:2015 quality-management alignment
ISO 14001:2015 environmental-management alignment
ISO 45001:2018 occupational health and safety alignment
ISO/IEC 27001:2022 information-security alignment for computerized systems
Control pillar

Document & Records Control

Controlled issuance, revision, distribution, retention, and retrieval of records relevant to quality and operations.

Control pillar

Receiving, Storage & Cold Chain

Processes covering inbound verification, warehouse discipline, temperature control, and product integrity during storage.

Control pillar

Dispatch, Delivery & Recall Readiness

Operational controls for dispatch, customer handover, nonconforming product handling, and market-withdrawal preparedness.

Control pillar

Complaints, CAPA & Self-Inspection

Issue intake, corrective-action follow-through, and internal review processes that support continual improvement.

Control pillar

Supplier Qualification & Monitoring

Qualification and oversight practices intended to support supplier consistency and documentation readiness.

Control pillar

Computerized Systems & Data Integrity

Systems-oriented controls relevant to ERP, WMS, and traceability-minded recordkeeping environments.

Visible SOP Catalogue

Controlled operating areas presented in a concise corporate format.

The website can present the existence of structured operating procedures without exposing every internal controlled document directly.

Quality Management System
Receiving & Inbound Checks
Storage & Warehouse Control
Cold Chain & Temperature Control
Dispatch, Delivery & Customer Receiving
Complaint & Compliance Handling
Product Recall & Market Withdrawal
Supplier Qualification & Monitoring
Document & Records Control
Self-Inspection & Internal Audit
Computerized Systems & Data Integrity
Training & Competency
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