Quality, control, and governance communicated for institutional review.
Berhan Pharma presents quality and governance through visible standards alignment, controlled-system language, and operational pillars that support buyer confidence.
Governance is communicated as operating discipline, not just policy language.
The public page acts as a concise overview for buyers and reviewers without exposing controlled internal documents directly.
Standards Alignment
Relevant standards and governance themes are presented as visible signals of maturity, traceability, and operating discipline.
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 Pillars
Operational controls are grouped into visible pillars so reviewers can assess them quickly.
Document & Records Control
Controlled issuance, revision, distribution, retention, and retrieval of records relevant to quality and operations.
Receiving, Storage & Cold Chain
Processes covering inbound verification, warehouse discipline, temperature control, and product integrity during storage.
Dispatch, Delivery & Recall Readiness
Operational controls for dispatch, customer handover, nonconforming product handling, and market-withdrawal preparedness.
Complaints, CAPA & Self-Inspection
Issue intake, corrective-action follow-through, and internal review processes that support continual improvement.
Supplier Qualification & Monitoring
Qualification and oversight practices intended to support supplier consistency and documentation readiness.
Computerized Systems & Data Integrity
Systems-oriented controls relevant to ERP, WMS, and traceability-minded recordkeeping environments.
Controlled operating areas summarized in a public-facing corporate format.
The public site can communicate the existence of structured operating procedures without becoming a raw document archive.