At Dr. Mwiko Health Solutions Ltd, we help pharmaceutical companies, distributors, and logistics providers implement and maintain full compliance with Good Distribution Practices (GDP), ensuring the quality and integrity of medicinal products throughout the entire supply chain.
Our GDP services are designed to meet the requirements of the World Health Organization (WHO), European Union GDP Guidelines (2013/C 343/01), and Kenya Pharmacy and Poisons Board (PPB) regulations, while also aligning with regional frameworks across Africa.
Our GDP Services
- GDP System Design and Implementation: Development of customized GDP quality systems, policies, and procedures that ensure safe storage, transport, and handling of medicinal products.
- Licensing and Regulatory Support: Assistance with the preparation and submission of documentation for Wholesale Dealer’s Licenses, GDP certification, and regulatory inspections.
- Temperature Control and Monitoring: Establishment of validated systems for temperature mapping, data logging, and deviation management during product storage and distribution.
- Audits and Gap Assessment:s Conducting internal and external GDP audits to evaluate compliance, identify deficiencies, and design corrective and preventive actions (CAPAs).
- Vendor and Supply Chain Qualification: Qualification and periodic assessment of logistics partners, transporters, and warehousing providers to ensure end-to-end GDP compliance.
- Training and Capacity Buildin:g Tailored training programs for warehouse, transport, and quality personnel covering key GDP principles, documentation practices, and regulatory updates.
- Deviation, Complaint, and Recall Management Implementation of traceable systems for managing product deviations, customer complaints, and product recalls in compliance with national and international standards.
Why Partner with Dr. Mwiko Health Solutions
- Expert Guidance: We bring extensive regulatory and operational experience in GDP implementation across Africa.
- Quality-Focused Approach: Every service is anchored in risk management, transparency, and documentation integrity.
- Regional Reach: We support clients with single-site operations or multi-country distribution networks across East, West, and Southern Africa.
- Inspection Readiness: Our proactive audit and documentation systems ensure continuous compliance and confidence during regulatory inspections.
At Dr. Mwiko Health Solutions Ltd, we understand that the quality doesn’t end at manufacturing; it extends through every link of the supply chain. Our GDP services safeguard product integrity, patient safety, and regulatory confidence from the warehouse to the patient.
